Regulatory Affairs Resume Samples

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E Tremblay

Eve

Tremblay

11307 Clyde Lake

Dallas

+1 (555) 166 8307

11307 Clyde Lake

Dallas

Phone

p +1 (555) 166 8307

Experience Experience

Phoenix, AZ

Regulatory Affairs

Phoenix, AZ

Hodkiewicz Group

Phoenix, AZ

Regulatory Affairs

Trading is interested in attracting people who share our core working values of honesty, integrity and respect for others
Supports senior Regulatory personnel in preparing new product marketing submission for the FDA (510k, PMA)
Provide regulatory and compliance interpretations to Marketing and Sales on labeling issues
Initiates and/or assists with trending of documentation metrics for company Management Review and additional meeting forums
Acts as training coordinator for ADC Germany, Austria and Switzerland
Management of customer requests regarding quality or regulatory related issues
Conducts product inspections, i.e.: receiving and integration with department administrative staff

Philadelphia, PA

Regulatory Affairs Administrator

Philadelphia, PA

Cartwright, Mosciski and Mitchell

Philadelphia, PA

Regulatory Affairs Administrator

Management of all filing, copying and preparation of new product submissions and variations under the direct supervision of the Regulatory Affairs Manager
To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485
Management of OPAL events, variations and approvals for SSA
Management of Product Information Files and Medical Device Technical Files
Assist in finding product information from Regulatory Affairs databases in response to requests from Intervet International
Setting up of SSA meetings for the team, ensure minutes and agenda are sent out prior to meeting and ensure minutes are captured and agreed prior to dissemination to team
Assist with regulatory export control and stickering as necessary

present

Philadelphia, PA

VP Government & Regulatory Affairs

Philadelphia, PA

Ledner-Cummerata

present

Philadelphia, PA

VP Government & Regulatory Affairs

present

Oversee all franchise renewals including managing.. efforts to ensure compliance with franchise obligations
Proven success driving progress and executing in a fast paced, dynamic and complex environment
Proven success developing people and building solid teams
Responsible for relations with Virginia and West Virginia state governments, including advocacy before the legislature, executive branch, and state agencies
Coordination with Division and Corporate leads on other regulatory matters involving Comcast
Consistent exercise of independent judgment and discretion in matters
Consistent exercise of independent judgment and discretion in matters of significance

Education Education

Bachelor’s Degree in Pharmacy

University of Delaware

Bachelor’s Degree in Pharmacy

Skills Skills

We also want those who can build on our business vision, are prepared to accept accountability and can achieve great results through teamwork
Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills
The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties
Determination of level will be based upon years of experience & demonstrated knowledge/skills
The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work
A mature and disciplined approach to work is essential as is the ability to coordinate the work of others
Fluent in English (written & spoken). Ability to communicate in German language (written & spoken) is a distinct advantage
Ability to plan and schedule multiple priorities in a concurrent fashion
Ability to review, collate and summarize scientific and technical data
Excellent problem solving and analytical skills

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15 Regulatory Affairs resume templates

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Senior Analyst Regulatory Affairs Resume Examples & Samples

BS in Business, Finance, or related field
5 years of industry experience required; preferably compliance experience
Series 7, 63/66, 9 and 10 required
Strong understanding of SEC, FINRA, MSRB rules/regulations, industry practice and how they apply to Stifel and affiliated firm policies and procedures
Demonstrated skills in organization, strong attention to details, prioritizing and managing time, multiple tasks and varying priorities in order to meet critical deadlines
Interpersonal Relationships — Developing, and maintaining constructive and cooperative working relationships with others, and sustaining them over time
Technical Writing – Able to gather information from research, existing documentation and subject matter experts, and effectively explain complex ideas to technical and non-technical audiences
Active listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times
Judgment and Decision Making – Considers the relative cost, benefits, and firm policy of potential actions and to choose the most appropriate action according to Firm and Team risk

Office of Regulatory Affairs Resume Examples & Samples

Identifying emerging regulatory policy issues for the Corporate and Investment Bank
Defining regulatory policy priorities through impact assessment and engagement with internal and external partners (internal business leaders, government relations, media relations, industry trade associations, etc.)
Leading internal working groups governing the development of regulatory policy strategies
Developing appropriate public policy positions and advocacy strategies
Leading/participating in dialogue with regulators and policymakers
Ensuring handoff to internal implementation leads as rules become final
Minimum of 10-15 years of experience
Strong background and understanding of fixed income and equity capitalmarkets, OTC derivatives, and futures markets
In depth knowledge of Dodd-Frank Act Title VII requirements, CFTC, SEC, andbanking regulations
Strong understanding of MIFID, EMIR, and European securities regulation
Strong written and oral communications skillls

Disney Vacation Club Management & Regulatory Affairs Internship Resume Examples & Samples

0 GPA or higher
Demonstrated problem Solving and analytical/critical thinking skills
Relationship/Partnering skills
Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint
Service Orientation (customer service)
Japanese and/or Spanish skill set
Experience working in Real Estate
Experience working in a bank environment, specifically dealing with mortgages
Disney knowledge
Currently enrolled as a junior or higher, or graduated within 6 months of the start date of this internship, in an accredited college/university earning a degree majoring in Business Administration, Law, Public Policy/Regulatory Affairs, Communications, Hospitality Management, Real Estate, Finance/Accounting or related major

Counsel, Regulatory Affairs Resume Examples & Samples

JD and BA/BS degrees
Active state bar membership
Minimum 6-8 years relevant regulatory experience, including law firm experience

Regulatory Development Manager FCC RC Regulatory Affairs Resume Examples & Samples

This role also needs to lead without authority and able to collaborate with multi stakeholders and deliver results. The role holder must be able to influence senior management and regulators by articulating clear business reasons for change initiatives
Bachelor’s degree in business, law, or related field or equivalent experience. LL.B or legal experience not required but considered an asset
Five to seven years proven and progressive financial services, compliance and/or legal experience or equivalent
Specialized knowledge of legislative compliance management programs as contemplated by OSFI Guideline E-13, legislation and regulatory directives relating to conduct, control of information, privacy, securities, financial crime relating as they apply to financial groups and extra-territorial laws applicable to Canadian financial groups such as Dodd Frank
Wide scope of knowledge and ability to review and understand complex regulatory regimes impacting a complex global financial group
Highly developed communications, negotiating, analytical, decision-making, organizational and planning skills
Wide scope of knowledge of financial institutions, including products, operations, systems and organization
Good understanding of all significant regulatory regimes applicable to Canadian financial institutions, a global financial group, and pertinent Group policies and external regulations

Office of Regulatory Affairs Resume Examples & Samples

Management Information Lead: Own the development and distribution of management reporting on emerging regulation to various stakeholders across the firm. Define and coordinate daily, weekly and monthly reporting across LOB and regional partners. Deliver organized, consistent results
Global Governance Coordinator: Manage Global Regulatory Policy Governance by partnering with Regulatory Affairs colleagues, LOB partners, Legal, Government Relations, and other key stakeholders to ensure escalation, ownership and issue capture for all emerging regulatory policy matters . Coordinate development of meeting materials for global and cross-LOB escalation forums and ensure follow up with appropriate stakeholders
Process improvement: Identify opportunities for process and efficiency improvement in tracking of emerging regulatory issues both within the team and across LOB and corporate partners. Drive systems, process, and technology improvements
Business management support: Assist with business management for the team including liaising with finance and accounting teams and ensuring proper strategic planning and forecasting for the global team
Briefings: Assist in the coordination and development of briefings for Senior Management for meetings with regulators, investors, and other stakeholders on regulatory policy issues
Ad-hoc projects: Assist with management of other reporting related projects, including presentations
Focus on service delivery / client satisfaction
Strong coordination and influencing skills, ability to work across business lines and jurisdictions
Must be detail-oriented and manage the details but can also summarize information at high levels
Strong time management skills with ability to manage multiple projects and time sensitive deliverables
Ability to work with multiple, complex systems and large volumes of information
Ability to help identify and recommend improvement in systems and processes
Proactive, responsive, creative and action oriented
Strong familiarity with bank regulatory issues strongly preferred

Regulatory Affairs Program Office Associate Resume Examples & Samples

Strong communication, presentation and project/program management skills
Candidates must be self-motivated, independent and organized
4-7 years of experience in financial services, management consulting and/or project management
Project Management Professional (PMP) or other Project Management (PMI) certification
Proficient with MS Access, Visual Basic for Applications (VBA)

Regional Regulatory Affairs Director Resume Examples & Samples

Develop and lead a global regulatory organisation, both centrally & regionally. Lead Regulatory KPI reporting, trending and review. Lead strategic vision for the R&D function through maximising the Regulatory landscape we operate in. Facilitate the promotion and protection of IP. Represent the company in negotiations and discussions with the key industry regulatory decision makers and competent authorities as required
Strategic responsibility for proactively influencing, leading & communicating on regulatory affairs externally & in parallel ensuring that all products are globally compliant for sale within EMEA
Maintenance and implementation of the Regulatory management system, Optiva, MDM etc
Create and drive the global regulatory organisation goals & objectives in line with the global regulatory strategy
Monitor potential changes in regulations and proactively liaise with relevant regional R&D representatives and/or local competent authorities in order to minimize any impact to the business
Ensure continuous regulatory expertise and knowledge across the organisation
Analysis and impact assessment of upcoming changes to existing regulations, partnering with the Supply Chain and advising on impact to supply chain and distribution processes
Support New Product Development through participation at product brief and artwork development stages. Providing expertise and direction on product classification and product claims during the NPD Process
Develop and manage the central regulatory team, ensuring a high level of regulatory expertise and resource which integrates with the global RD&A/regulatory organisation. (50 people)
Liaison & communication with Corporate Legal on strategic and operational regulatory issues
Minimum of 5 years work experience as a Functional leader for a Global Food business or related industry
Minimum of Degree level Food science or Science related disciplines,
Expert observation, analysis and judgement (i.e. analytical and objective mind-set)
Strong background in Food Science & Regulatory standards
Knowledge of Process management systems and document control
Ability to work with cross-functional teams at multi levels within the organization
Excellent Interpersonal, communication, coaching and conflict management skills
Ability to lead and project manage a cross functional team
Proven track record of driving continuous improvement and change management initiatives
Direct Customer Management experience essential

Office of Regulatory Affairs Corporate Summer Intern Ny Resume Examples & Samples

Strong interpersonal leadership and influencing skills
Results-orientation - takes initiative to identify areas to add value and executes quickly and accurately
Excellent project management skills and attention to detail, ability to prioritize issues and manage competing tasks
Analytical and data management skills
Excellent communication skills (both oral and written)
Outstanding ability to analyze problems, identify key dimensions of a problem and propose solution
A track record demonstrating a high level of personal initiative, setting and achieving challenging goals, and demonstrating entrepreneurial leadership
Demonstrated interest in regulatory policy issues affecting the financial services industry
Intermediate to advanced MS Excel, Word and PowerPoint skills

Regulatory Affairs NDA Consultant Resume Examples & Samples

8+ years of Regulatory experience respectively within the Pharmaceutical or Biotechnology industry
Bachelor's Degree in a Scientific field
Experience directing the preparation of eCTD NDA submissions
Solid understanding of FDA regulations and ICH guidances, as well as comprehensive experience in the drug development process
Solid problem solving and negotiation skills
Ph.D. or Pharm. D
Regulatory Affairs certification

Office of Regulatory Affairs Resume Examples & Samples

Identifying and analysing legislative and regulatory proposals on a variety of upcoming financial regulatory change initiatives in terms of application to and impact upon current JPM business. Proposals are predominantly EU and UK driven but are considered, where relevant, in the context of the international agenda e.g. IOSCO, FSB, and emerging US policy, to ensure a holistic appreciation of policy goals
Building relationships and working with a wide range of stakeholders (line of business, compliance, legal, government affairs, and finance) in determining the firm's views on proposals and the appropriate mechanism for advocacy/response
Drafting position papers, response documents and other analytical pieces for a variety of audiences
Representing the firm’s views in discussions with regulators, legislators and other appropriate external stakeholders
Bachelor's Degree or equivalent in a complementary discipline would be a distinct advantage – including candidates with a legal qualification/background
Proven professional experience with an investment bank, regulatory body or private law firm
Sound working knowledge of financial services regulation in the EU
Excellent verbal/presentation and written communication skills
Flexible and proactive in approach
Good basic grasp of prudential regulation would be a distinct advantage, as would competency in a European language

Office of Regulatory Affairs Executive Director Based Resume Examples & Samples

Chief Operating Officer for the group:manage strategic planning, regulatory relationship management, resource allocation, hiring, internal and external communications including with industry bodies and trade associations
Leading and supporting virtual teams: Partner with ORA team members, finance, strategy, risk, government relations, communications and LOB teams to develop positions on high priority regulatory policy matters
Head of Regulatory Affairs for the Commercial Bank:identify emerging regulatory policy issues, define regulatory policy priorities, and lead dialogue with regulators and policymakers to achieve optimal outcomes for the line of business
Manage internal governance, reporting, and coordination among regions and lines of businesson emerging regulatory reform issues, ensuring appropriate issue capture, escalation, internal communication, and accountability
Lead firm-wide and cross-region projects on global regulatory reform issues including development of analytical support for policy positions
Manage team of 5 which supports executives globallyon a project basis covering a range of global and domestic regulatory policy issues (including drafting of oral and written presentations and speeches)
Significant regulatory experience including team management experience
Experience with bank regulatory policy issues
Strong relationships with regulators, policymakers, and trade associations globally
Excellent analytical, organizational, and problem solving skills
Ease working across a range of geographies
Ability to effectively engage senior leaders around the firm
Ability to clearly communicate and present information both verbally and in writing
Advanced technical skills in Excel and PowerPoint
Master’s Degree or equivalent in a related subject

Regulatory Affairs Consultant Resume Examples & Samples

The propose of the role is to provide Chemistry Manufacturing and Controls (CMC) Regulatory Guidance and strategy to support the development of assigned projects within the Biologics and Vaccines portfolio, up to and including MAA / BLA submission
The role will also have responsibility to author and manage the submission of clinical trial applications (INDs, IMPDs, CTAs), briefing documents, etc. as they relate to CMC
Provide CMC regulatory advice and guidance to co-development teams that manage the development of Biologics and Vaccines
Plan, manage, author and submit CMC content for clinical trial applications, amendments etc
Ensure that submission and approval schedules are met to facilitate timely conduct of clinical trials
Develop high quality responses to BOH questions arising from clinical trial application submissions
Develop BOH communication materials as required, e.g. BOH meeting briefing documents, scientific advice requests
May provide strategic input and support the development of the initial MAA / BLA Complies with Department and Company Standard Operating Procedures (SOP's) relevant to the position

Regulatory Affairs Operations Lead Resume Examples & Samples

Bachelor's Degree in a Natural Sciences field
Experience with either EPA or FDA registered products
Exceptional negotiating and influencing skills
Experience in Consumer Products industry

VP-office of Regulatory Affairs Resume Examples & Samples

Identifying and analysing legislative and regulatory proposals on a variety of upcoming financial regulatory change initiatives in terms of application to and impact upon current JPM business. Proposals are predominantly nationally-driven but are considered, where relevant, in the context of the international agenda e.g. IOSCO, FSB, and emerging US policy, to ensure a holistic appreciation of policy goals
Delivering verbal briefings and analyses to a wide range of stakeholders, including senior management
Participating in advocacy meetings with business and government relations colleagues and other internal stakeholders
Representing the firm’s views at, and coordinating with, all major industry associations in their submissions, articulating positions and playing a proactive role in forming opinions in a collegiate atmosphere
Higher degree or professional qualification in a complementary discipline would be a distinct advantage – including candidates with a legal qualification/background
Sound working knowledge of financial services regulation in the APAC region
Wide ranging knowledge of banking and analogous businesses and of their public policy context
Able to work well both autonomously and in a team environment, holding self accountable for deliverables and able to work to strict deadlines
Confident in dealing with senior management
Outstanding analytical skills
Ability to manage multiple workflows
Ability to work in an open plan team environment
Good basic grasp of prudential regulation would be a distinct advantage, as would competency in a regional language

Regulatory Affairs Advisor Resume Examples & Samples

Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible forclose liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval
Maintenance of marketing authorisations for nominated client via a range of regulatory activities including submission of variation applications and MA renewals
Communication with the appropriate competent authority to answer questions and obtain timely approval for changes
Implementation and communication of MA changes. Ensuring all compliance activities are correctly managed
Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management in line with regulatory requirements
Maintain sound knowledge of European regulatory requirements, regulations and guidelines to provide advice and expertise internally for matters related to client products
Provision of guidance/technical support in the preparation of EU CTD dossiers applications
Builds and maintains strong relationships with different Competent Authorities to ensure ease of access and influence
Works collaboratively with other department colleagues to share best practice and information and to ensure a consistent approach with both Competent Authority & within company
Support other team members with the maintenance of the Quality Management System and ISO 9001, including generation and review of SOPs, reports and other quality documentation
B.Sc. Minimum or pharmacy primary degree
Greater than 3 years experience of human medicinal product Regulatory Affairs in the Pharmaceutical Industry
Experience with electronic submissions desirable
Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice
Experience in the preparation and submission of new applications, variations and renewals for multiple EU markets
Experience in the management of DCP's, Centralised or other European procedures
Ability to project manage across a diverse and complex portfolio of products and priorities
Ability to get on with people, to influence people both internally and externally and to achieve objectives
Above average attention to detail and solid interpersonal, communication and organisational skills required
Excellent attention to detail with Client Care an integral part of your work ethic
Confidentiality and discretion
Motivated self-starter

Regulatory Affairs Advisor Resume Examples & Samples

Ability to take ownership/ regulatory responsibility for key product(s) for nominated client(s) and be responsible for close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval
Medical writing, review of SPC, labeling and management of national prescribing information and core data sheets (CDS) during product lifecycle
Review of clinical and safety draft reports created by client and provide feedback within the required timeframes
Ability to work effectively as part of a team with a strong focus on meeting target deadlines
Review and appraisal of PSURs, and responses prepared by client prior to submission to competent authority
Apply regulatory and scientific knowledge to determine solutions and solve complex problems
Represent at related events and possess the ability to drive the Company forward in a positive light at all times
Builds and maintains strong relationships both internally and externally
Having some responsibility for training and coaching colleagues in your area of expertise (i.e.Pharmacovigilance)

Government & Regulatory Affairs Executive Resume Examples & Samples

At least 10 years experience in a leadership role that involves government or government affairs
At least 5 years experience in working for a large corporation or effective trade association is preferred
At least 1 year experience in working in government at senior level is a plus
At least 5 years experience in global acumen, balanced judgement
At least 1 year experience in verbal and written communication skills, must be excellent

Director Government & Regulatory Affairs Resume Examples & Samples

Prominently positioning Visa with political, regulatory and policy decision-makers to support and drive business opportunity for Visa by shaping the regulatory landscape for electronic payments
Support the implementation of a Government Relations strategy for China in close coordination with the Senior Director, Government Affairs and Public Policy, China Country Manager, along with other relevant Visa business leaders
Monitor the regulatory and political landscape for threats and opportunities to Visa's business and communicate this intelligence to locally-based business leaders, functional colleagues and global management
Support Visa's relationships with officials at key government agencies, including the education of officials from these agencies about the value of Visa thereby improving the company's overall reputation
At least 5-10 years in relevant corporate position, regulatory or government agency and/or consultancy serving equivalent clients

Manager Policy & Regulatory Affairs Resume Examples & Samples

Contribute to the development of global public policy and Government Affairs objectives by
Supporting the Bank's relationships with government contacts in Canada and other key markets
Identifying policy trends, threats and impacts to the Bank’s operating environment and business line plans, contributing to the Bank’s strategic plan and other internal processes
Proactively developing and implementing strategic and tactical plans and responses to policy developments in light of Bank and government priorities
Concisely synthesizing large amounts of information and communicating summaries, positions and recommendations in simple, concrete terms
Contribute to integrated communication strategies and tactics related to the Bank’s policy agenda and its reputation with government and related stakeholders by
Providing, and collaborating on, policy and research communications including issues management, reputational risk and crisis communications
Provide strategic advice and counsel by
Contributing to the development of briefing material for the CEO, Executive Management Team and SVP for meetings including those related to the elected officials, regulators, foreign governments, international organizations
Managing relations with the Canadian Bankers Association (CBA) and the Institute of International Finance (IIF), and supporting senior executive and senior management officers who are members of CBA senior committees and IIF committees
Providing intelligence, analysis and judgement on the global regulatory environment and specific policy issues of relevance to the Bank
Collaborating with the rest of the Government Affairs team to support work on developing briefing materials, policy analysis, and integrated counsel that combines policy and political analysis
Manage and keep track of political risks, policy and communications opportunities at an all-bank level and across its international network by
Ensuring comprehensive and timely capture of regulatory, policy and market events and trends, timely analysis and proactively preparing communications materials
Proactively identifying emerging policy, political, consumerist and market developments across multiple jurisdictions and international forums for review with senior officers of the Bank, including liaison with business lines and corporate functions (e.g., Strategy Management, Economics, Compliance, Finance, General Counsel)
Contribute to the effective functioning of the Government Affairs team by
Building effective working relationships across the Public, Corporate and Government Affairs team and with various business line and corporate function contacts
Maintaining customer focus
Some prior experience in public policy, government relations and/or communications

Associate Director, CMC Regulatory Affairs Resume Examples & Samples

Provide CMC RA leadership within RA and on cross-functional CMC teams
Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls
Provide CMC regulatory strategy for proposed changes, new development efforts, content message points, or other related activities, for commercial and/or development programs
15%
Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products
Lead other development functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements
Evaluate manufacturing change controls, assess regulatory impact, and support their implementation
B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
8 - 10 years of drug development experience including significant strategic experience in CMC regulatory affairs with a strong biologics background
Demonstrated leadership in regulatory strategy and experience in regulatory interactions

Office of Regulatory Affairs Resume Examples & Samples

Identify emerging regulatory policy issues emerging from North American and global regulators and policymakers
Advise internal constituents on North American and global regulatory policy matters
Effectively communicate JPMC’s regulatory policy positions through a variety of channels (written responses, bilateral meetings with policymakers, trade associations, legislators, etc.)
Represent JPMC in public forums, including conference participation, speeches, presentations, and discussions with the media
Manage relationships with US Regulators and policymakers including at Treasury, Federal Reserve, FDIC, and the OCC
15+ years of experience in a senior leadership role, managing associated risks, policies and budgets
Extensive current knowledge and understanding of regulatory policy and affairs
Expert knowledge of the enhanced prudential standards for large U.S. bank holding companies and foreign banking organizations including liquidity, risk management, and capital
Proven leadership and partnership skills with proven ability to effect change within a large matrixed organization
Excellent oral and written communication skills with experience representing an institution in public forums
Strong preference for legal, regulatory agency, government or trade association experience
Expert knowledge of bank/market regulations strongly preferred

Publishing Assistant of Regulatory Affairs Resume Examples & Samples

1+ year of experience working in a Regulatory Affairs Department or in the Publishing field
Bachelor's Degree in a Science-related discipline or equivalent experience
Understanding of eCTD submissions and current guidelines

Head of Regulatory Affairs Resume Examples & Samples

Establishes and implements short and long term strategies to deliver products and services to clients within reasonable schedules and budgets. Collaborates with Life Sciences Business Process Services (LS BPS) Regulatory leads and sales professionals to determine and develop product strategy and assess risks
Directs staff in implementation of program, product, and client management strategy. Supports team related to client and regulatory deliverables and submissions. Maintains interface with lead project managers on technical aspects of projects as well as cost and schedules to ensure timely delivery, where necessary
Monitors and maintains industry and market expertise and awareness of new technologies and companies to support new business. Forms and maintains critical high-level relationships with outside governmental and industrial entities for the collaboration and development of new business initiatives
Oversees, collaborates and conducts critical evaluations of new product development priorities, as well as existing product improvement and applications priorities, including evaluation of safety and efficacy data, significant marketing opportunities, competition, core competencies, sources of supply, manufacturing requirements, regulatory issues, profitability and other applicable criteria to support client engagements as necessary
Manages new product and partnership development, existing product improvement and development process, including coordination of interdepartmental responsibilities
Maintains currency with technical and regulatory activities on pharmaceutical and biotechnology programs. Provides technical expertise and training opportunities for staff to maintain high level skills
Selects and hires employees. Trains and evaluates employees to enhance their performance, development and work product. Addresses performance issues and makes recommendations for personnel actions. Motivates and rewards employees including providing salary increases, bonuses and promotions within allocated budgets and company guidelines
Prepares and recommends operating and personnel budgets for approval. Monitors spending for adherence to budget, recommends variances as necessary
Master's degree or equivalent combination of education and experience
Twelve or more years’ experience in one or more of the following areas: biotechnology, regulatory, Chemistry, Manufacturing, and Controls (CMC), clinical, or non-clinical
Twelve or more years’ experience in the development of pharmaceutical / biopharmaceutical industry Strong interpersonal skills to interact with customer and team members
Experience in leadership, supervisory or management
Experience in managing and developing senior level staff
Experience working with company products and offerings
Knowledge and proficiency of Food and Drug Administration (FDA) and international document submission requirements and regulations Strong project management skills to coordinate and manage internally and externally
Excellent verbal and written communications skills to effectively share concepts, ideas, information and suggestions with others
Strong analytical and problem solving skills
Strong interpersonal skills to establish and maintain client relationships through executive level
Ability to multi-task and work on multiple functions simultaneously
Ability to anticipate internal and client needs

Manager Government & Regulatory Affairs Resume Examples & Samples

Responsible for day-to-day contact regarding local regulatory, franchising, community investment and public policy matters for assigned footprint within the Region
Serve as a liaison between the company and our franchising communities, non-profit community partners and community business leaders
Responsible for franchise renewals, transfers and all related compliance issues
Represents the company before municipal boards and commissions; at community events; serves on boards of relevant organizations
Advocates for the company throughout assigned footprint and implements strategic plans
Works closely with other departments to further business objectives and to facilitate business opportunities
Prepares franchise-related documents, supports cases before government regulatory agencies, skilled in researching & analyzing
Identifies issue in the service footprint that affects the business and recommends action
Assists with state and federal legislative matters as needed
Advise on political issues within assigned footprint, alert to competitive environment and marketplace conditions
Harness support in the field for company’s initiatives through champion building and networking
Identities and coordinates community events & sponsorships supportive of business objectives and policy initiatives
Works with non-profit, civic and service organizations to further company’s goals of good corporate citizenry
Participates in all corporate giving, volunteer and grassroots programs; by way of example-Comcast Cares Day, Internet Essentials, United Way
Regular, consistent and punctual attendance. Must be able to work nights and

Business Analyst, Regulatory Affairs Resume Examples & Samples

University degree in business
Excellent understanding of accounting and financial concepts and processes (professional accounting designation preferred)
Ability to collect, aggregate, analyze, organize and clearly communicate large amounts of financial and operating data
High level of proficiency with Microsoft Excel
Strong research skills
Bilingual (English and French)
Proficiency with Microsoft Word and PowerPoint
Experience with Bell’s financial information systems

Scientific Regulatory Affairs Executive Resume Examples & Samples

Apply the Group’s regulatory affairs strategy and help implement regulations, notably for cosmetics and chemicals, in product development and marketing, with focus on operational support to the APAC country Scientific and Regulatory Affairs teams so that they can ensure market access procedures required by the local regulations
Provide technical and regulatory support throughout the product lifecycle, from initial research to final marketing Participate in compiling regulatory reports in line with quality standards and deadlines Contribute to ensuring compliance with relevant rules and local regulations for product market access
Contribute to improving or developing information systems to support APAC country Scientific & Regulatory Affairs team
Contribute to cross-disciplinary projects initiated within the technical-regulatory network

Office of Regulatory Affairs Resume Examples & Samples

Project Support: Support senior group leadership and the Central Team on longer-term research and analytical projects related to regulatory policy or policy themes
Research Project: Conduct a research project related to emerging regulatory policy and present findings and proposed next steps to group management
Management Reporting: Assist with drafting and research related to ORA’s various management reports
Research and Analysis: Perform ad hoc projects and research related to emerging regulatory policy
Strong interpersonal leadership and influencing skills
Results-orientation - takes initiative to identify areas to add value and executes quickly and accurately
Judgment and professional maturity to handle sensitive information and work with senior management
Excellent communication skills (both oral and written)
A track record demonstrating a high level of personal initiative, setting and achieving challenging goals, and demonstrating entrepreneurial leadership
Demonstrated interest in regulatory policy issues affecting the financial services industry

Regulatory Affairs & Quality Systems Manager Resume Examples & Samples

Works with senior management to develop regulatory strategies for FDA approvals. Directs the division’s FDA regulatory activities and initiative, assures the quality of its records and products and ensures timely submissions, reports and filings to meet FDA’s regulatory requirements
Manages the Quality Systems Specialist position to ensure quality system compliance with all state and federal regulations, to include the hiring process and performance appraisal
Responsible for regulatory guidance to the division’s product development teams
Responsible for regulatory submissions of FDA pre-market notification and 510(k)
Responsible for regulatory reports of MDR (Medical Device Reporting) and Baseline Reporting to the FDA
Monitors and audits GMP (Good Manufacturing Practice) and cGMP (current GMP) policy and procedures
Maintains correspondence and other records of all interactions with the FDA CDRH, FDA LA District Office and State of California – Health and Human Services. Coordinates and direct strategy and conduct all meetings with the FDA, and regular interaction with the FDA
Requires a bachelor's degree in a relevant field or equivalent experience
Minimum of 7 years of relevant industry experience
This position requires superior verbal and written communication skills and negotiating skills, and the ability to ensure that the division adheres to the FDA quality and regulatory guidelines

Compliance & Regulatory Affairs Quality Assurance Resume Examples & Samples

Working with multi-departmental teams in analyzing complex cross departmental issues (Front Office, Operations, Risk Control, Product Control, Finance, GC, Compliance and IT) identifying inefficiencies, control weaknesses and constraints from on-boarding, trade capture/business event management, risk through to settlements, P&L validation, price testing, financial control and regulatory reporting
Analyze and suggest improvements to F2B flows with an emphasis on understanding risks and issues along the following dimensions
Strong cross business product knowledge; Retail banking, HNW and UHNW Banking products, Securities, FX, OTC Derivatives, Equities, Credit, Rates and commodities
Technically strong in the following programmes – Excel, Powerpoint. Sharepoint, Macro/VBA, Xcelsius would be an advantage but not a necessity
Business Analysis; the ability to breakdown and understand a problem or process and provide a solution displayed in a presentation also including high level architecture and mapping
Project management: leading a project, managing key stakeholders, build relationships across the Bank with FO, PC, Risk, Ops, FA, Reg and IT
Solid business understanding across the bank including the Front to Back processes for various products including how the various functions fit against each other
Deep knowledge of the full trading lifecycle, business events and reporting
Strong market knowledge required, the candidate should have a view of the key dimensions in the current financial market
The ability to support control model analysis
Experience in target architecture and process improvement delivery, with IT components / IT architecture
Strong academic background, ideally post graduate business/technology or equivalent
Strong understanding of business process and technology in a major institution Banking
OE Black Belt Qualification desireable

Compliance & Regulatory Affairs Resume Examples & Samples

Involved in the overall daily operating activities for the function, including managing all human capital processes, e.g., oversight over recruiting processes, coordinating training activities for the function, in partnership with Talent Development, ensuring mandatory training requirements are met, and the MyPerformance.process is completed in a timely manner
Ensure that MICOS supervisory controls are completed across the CCRO COO functions supported
Support with the day-to-day financial management activities across the CCRO COO functions you support, including: forecasting of financials and headcount, tracking financial and headcount actuals against budgets, cost center ownership and sign-off, maintaining the GAD approval matrix, processing of vendor invoices, raising POs, overseeing and coordinating vendor contracts, working in partnership with Non-IT Sourcing,
Implement, drive and track cost efficiency initiatives across the CCRO COO function you support, e.g., OnePC per person, personal communications initiatives (BlackBerries,mobiles), etc
Support and implement the workspace strategy for the CCRO COO functions you support
Serve as the BCM coordinator for your location
Coordinate and provide all updates to outsourcing inventories, RRP critical service matrices, etc. Manage
Organize CCRO COO meetings for the functions you support, e.g., team meetings, town halls. This includes: setting the agenda, determining discussion topics; and, preparing discussion materials
Contribute, prepare and/or review discussion materials in a timely manner and with high quality for meetings led by or with the CCRO COO
Coordinate all changes in the organizational structure for CCRO COO, ensure that changes are reflected in all organizational charts or governance documents, Implement changes in approval flows in downstream systems to reflect organizational changes, accordingly
Manage communications activities, in partnership with Corporate Communications and CCRO COO Business Manager, for the functions you support including writing and editing communications, proper syndication of all communications to ensure that stakeholders are aware of and agree to the content of the communications, publishing and distribution; coordinate updates to intranet sites of the CCRO COO functions you support, as required
Support the CCRO COO Business Manager on various strategic initiatives for the CCRO COO function
Use appropriate governance within area of responsibility, i.e., regular management meetings (incl. minutes and action trackers), controls and procedures to escalate and resolve Supervisory Issues
Ensure that all areas in CCRO COO have supervisory protocols for new employees, employees whose job responsibilities change, and employees who leave are in place
Retain, direct, motivate and develop staff in order to reasonably ensure that employees under their supervision are competent to perform their functions and receive appropriate training
Plan and utilize resources proactively and efficiently
Responsible for delivery and management to assigned budget for CCRO COO as well as CRA division
Ensure that areas under management operate without significant operational, financial or reputational risks by performing the necessary control tasks
Ensure that all information produced by CCRO COO for regulators are updated, reviewed and archived, appropriately
7-10 years of experience in a similar position within a bank or financial services institution; experience working in a strategic management consultancy; knowledge and network in Credit Suisse is a distinct advantage
Strong analytical and quantitative skills; likes working with numbers; some accounting / controlling knowledge an advantage
Team player who is flexible; able to thrive in a fast changing environment where there is an opportunity to perform a wide variety of tasks at all levels
Attention to detail is a must; focus on delivery of a high quality work product in a timely manne
Good organizational and communication skills
Ability to manage own time effectively, work independently but know when to seek guidance, and take accountability for actions
A self-starter and fast learner with creative problem-solving skills
High integrity and ability to maintain confidentiality at all times
Very good knowledge of Excel, PowerPoint and MS Word
Strong written/spoken English language skills
A university degree or equilvalent

Regulatory Affairs Resume Examples & Samples

Manage all aspects of Document Control
Provides regulatory expertise in regulatory labeling requirements
Ensure that all Design History projects comply with regulatory, developer, and company requirements for HS products
Provide regulatory and compliance interpretations to Marketing and Sales on labeling issues
Assists in training staff on pertinent regulatory and pertinent issues, as assigned by department senior staff. Topics include inspections, document compliance, etc
Conducts and/or participates in specialized audits, i.e.: documentation, integration, CAPA, procedure manuals, labeling, etc
Coordinates department annual records retention projects to ensure compliance with regulatory requirements
Conducts product inspections, i.e.: receiving and integration with department administrative staff
Participates in CINC Compliance meetings
Participates in company Quality Management Review meetings
Assists department and senior management and participates in regulatory investigations. Participation includes, but is not limited to: answering questions on documentation, taking inspection notes with Inspection Coordinator, identification of relevant inspection documents, etc
Assists with Complaint integrations into Complaint database
Initiates and/or assists with trending of documentation metrics for company Management Review and additional meeting forums
Education: Bachelor’s required. Preferably in science or healthcare discipline
Experience Required: 0-2 years in a medical/pharmaceutical company preferably with responsibility for documentation compliance
Excellent understanding of documentation (good documentation practices) required in a medical device/pharmaceutical environment
Excellent communication skills, both orally and in writing
Experience interfacing with regulatory agencies, i.e., FDA is highly desirable
Ability to provide routine trending on documentation projects, as required

VP Government & Regulatory Affairs Resume Examples & Samples

Oversees state legislative government and regulatory affairs activity for all states in assigned area(s) and is responsible for securing and maintaining franchise operating authority
Collaborates with senior management and State Government Affairs personnel to develop and implement strategies that shape public policy regarding proposed legislative and regulatory initiatives
Sets strategic direction and overall guidelines for franchise renewals, including financial calculations and parameters for renewals. Serves as escalation point for issues for complex and/or difficult franchise renewals, franchise transfers, and franchise non- compliance issues
Drafts, analyzes, and/or presents legislation, amendments, and testimony as necessary
Monitors state legislative and regulatory activities affecting Company and the cable industry
Provides leadership and supervision to the Government and Regulatory professional team, including staffing, performance management, compensation administration, office management, etc

Executive Director Product Safety & Regulatory Affairs Resume Examples & Samples

Build a Regulatory and Compliance practice for NewAvon which ensures all NewAvon products have met all product safety and regulatory requirements
Develop strategies to ensure timely compliance with all emerging federal and state ingredient/product regulations; monitor same and actively participate in commercial associations involved in monitoring/structuring regulations to get early warning of potential issues. Active NewAvon member of the PCPC
Ensure all product registrations and notifications are filed in line with regulations (voluntary and mandatory)
Approve product labeling and review/approve claim substantiation with Legal
Provide direction on compliance issues including FDA/USDA/Canadian customs inquiries detentions and ingredient non-conformance (eg., out of spec)
Significant experience in managing regulatory and compliance issues across categories in personal care (focus on skincare a plus); broad knowledge of the science and chemistry of beauty products
Consciously aware of trends in regulatory environment for beauty, personal care and nutrition; has experience in similarly regulated markets with a working knowledge of compliance requirements
Understanding of FDA/USDA/Canadian customs requirements, product registrations, and notification requirements
Familiarity with the legal restrictions around claims substantiation and product labelling
Strategic thinker â€“ able to bridge the gap between tactical daily delivery of regulatory compliance and developing a market leading, brand enhancing, product safety practice
Demonstrated ability to work closely with Legal, Marketing, Sourcing in assessing risks involved with claims substantiation and new materials
Focused and organized
Must have led similar function before with proven track record for delivering outstanding results
Experience in several aspects of consumer goods, beauty/cosmetics, and/or health and wellness
Ability to take full ownership of complex regulatory issues; understands the nuances of working with a restructured organization; strong program management skills a plus
Track record of successfully resolving product safety or compliance issues
Ability to communicate complex regulatory/compliance issues effectively to a variety of stakeholders
Self starter, able to work independently and take the initiative
Strong leadership, mentoring and collaborative skills
Experience with Canadian regulatory awareness and business environment a plus

Paralegal, Insurance Regulatory Affairs Resume Examples & Samples

Serve as primary paralegal to Insurance Regulatory Affairs attorneys and, as needed, to rest of the Regulatory Affairs and Strategy group
Monitor regulatory developments that apply to and affect business operations of the firm
Track proposed and final rule changes, regulatory guidance and other significant regulatory events/matters and assist attorneys with preparation of regulatory reports
Establish and maintain a repository of information on rules, regulations and other regulatory guidance that impact business operations
Establish and maintain a repository of key regulatory contacts and pending and closed matters
Track and coordinate responses to regulatory requests and inquiries
Assist with preparation and submission of filings with state insurance regulators
Provide support, review and organize information and documents for financial and market conduct examinations
Assist with research and recommendations for internal partners regarding regulatory inquiries
Additional duties as assigned
Minimum of 3 years’ paralegal experience in a professional services organization, or financial services organization or law firm is required
Ability to conduct basic legal research and draft responses regarding regulatory inquiries is required
Bachelor’s Degree is preferred; Paralegal certification strongly preferred
Experience with life insurance issues and/or financial services regulation strongly preferred
Experience drafting regulatory filings and maintaining compliance records preferred
Experience tracking proposed regulations, guidance, circular letters, etc., preferred
Proficiency in MS Excel, Outlook, PowerPoint, and Word
Strong organizational skills, including database management
Attention to detail and ability to organize and prioritize tasks

Corporate Office of Regulatory Affairs Executive Administrative Assistant Resume Examples & Samples

Assist regulatory policy professionals including calendar and contact management, travel, phone coverage, meeting set up, and ad hoc projects
Schedule meetings with senior level internal and external stakeholders (including regulators and policymakers), which may involve numerous time zones
Work effectively with other administrative assistants to coordinate/plan meetings, conference calls and conferences, and manage the use of the visitors office
Review markups and input revisions to Word and PowerPoint documents
Format PowerPoint documents
Book international and domestic travel arrangements, and organize itineraries
Submit and manage technology requests (arranging purchase and installation of technology, troubleshooting technology issues) and obtain supplies
Assist with staff onboarding and off boarding, which includes requesting equipment setup and system access
Provide backup support as needed/requested for other executive assistants on the team
Ability to work effectively in pressured environment and partner effectively with peers who cover team members in the ORA's other locations, in support of team goals
Exhibits a positive, common sense, constructive attitude with character to drive schedules and help manage time effectively
Proven technology skills and highly proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook)
Strong communication style and good judgment
Is flexible, willing and open to challenges and changes
Can follow up effectively without prompting and keep one step ahead of arrangements and requirements
Anticipates needs
High level of attention to detail and delivers high quality results
Ability to navigate core technology systems, such as expense and procurement, requisitions, etc
Experience interacting with government and regulatory officials, both domestically and internationally

Regulatory Affairs Coverage Officer Resume Examples & Samples

Regulatory affairs liaison between key U.S. regulators, primarily the Federal Reserve Bank of New York (FRBNY) Onsite Team and the SEC, and key departments within Credit Suisse
Mandate focuses on relationship management (internal and external) and includes managing day-to-day interactions and requests between Credit Suisse and the FRBNY Onsite Team and SEC including facilitating prompt response to questions, assuring delivery of ongoing information, planning and recording management meetings, supporting ‘point in time’ examinations, tracking and reporting interactions and prompt resolution of issues
Excellent interpersonal and communication (written and verbal) skills
Exceptional comprehension skills and acute attention to detail
The ability to work with varying levels of management and with varying levels of expertise
Highly proficient in Microsoft Office
Proactive self-starter

Director, Scientific & Regulatory Affairs Resume Examples & Samples

Provide thought leadership and strategic oversight for compliance of new products, ingredients, labelling and claims across the CCNA product portfolio for Global Marketing, R&D and other functions. Influence the new product pipeline and M&A opportunities, and develop solutions to minimize regulatory barriers
Partner with the business to identify regulatory needs to meet current and future needs, and develop and execute strategies to create a regulatory environment that provides flexibility to the business
Provide expertise to guide the business in finding solutions to regulatory compliance issues that affect our products, packaging, ingredient, labelling and claims
Maintain a strong network of experts, government agencies, industry peers and other stakeholders needed to maintain a favourable regulatory environment for the company. Represent the company externally on relevant trade and scientific organizations
Proactively inform the leadership of emerging regulatory issues of impact to the business and identify strategies to address them
Identify and implement best practices that drive efficiency and accuracy of SRA compliance processes
Direct the activities of the SRA compliance team and provide leadership and motivation including coaching and mentoring team members
Advanced Regulatory Knowledge: Expert knowledge of the food regulatory and political landscape (e.g., regulations, issues, federal/state/local government responsibilities and interactions) affecting food and beverages globally. It includes the ability to manage complex regulatory issues affecting products, ingredients, packages or claims
Basic Toxicology: Knowledge of basic beverage ingredient safety
Consulting: Ability to provide timely, specific information, guidance and recommendations to help groups, managers and others make informed committed decisions that lead to sustainable impact
Food Law: Knowledge of food law as it applies to ingredients and packaging. This includes knowledge of required/allowed levels and restrictions for ingredients or knowledge of where this information exists and how to access it
Food Science: Knowledge of principles and techniques of basic food science and their application to the beverage industry
Nutrition: Knowledge of basic nutrition concepts and definitions involved in basic nutritional labeling
Process Improvement: Ability to analyse existing processes and identify more efficient ways to accomplish goals and meet customer and client requirements; ability to continuously improve processes through regular assessment and adjustment
Scientific & Regulatory Affairs expertise: A subject matter expert in regulatory affairs with good understanding on regulations on food labeling, global nutrition policies and action plans. General knowledge of beverage ingredients and manufacturing and food industry. Ability to advocate company positions and to bring solutions to address regulatory risks
Technical and Ingredient Policies: Expert level knowledge of Company policies affecting ingredients, product composition, labels and/or technical claims
Strategic Direction: Ability to create a clear view of destination for the functional area, help others understand how and why things will be different when destination is achieved, build commitment and inspire action toward the destination
Successful Team Leadership: Ability to use appropriate methods and a flexible interpersonal style to build a cohesive team and facilitate completion of team goals
Management of the Performance of Others: Ability to plan and support the contributions of individuals and the development of their skills and abilities so they can fulfill current or future job/role responsibilities more effectively
12-15 years’ experience (preferably directing food regulatory compliance programs); leadership skills and people management experience

Labelling & Regulatory Affairs Admin Resume Examples & Samples

Bachelor of Science or related fields
Experience in Regulatory Affair, import, cosmetics, food or consumer products is preferred
Excellent MS Excel skills (V lookup, Pivot table)
Able to work under pressure and manage time efficiently
Pro-active, highly organized and attention to details

Japan Compliance & Regulatory Affairs Division Control Room Compliance Officer Resume Examples & Samples

Maintain Watch and Restricted Lists
Review Equity Research for compliance with quiet periods (e.g., IPO, Secondary, and Lock-Up expirations)
Conduct compliance training to relevant divisions
Look to continuously improve the Control Room operations identify risks and contribute to the efficiency and effectiveness of the function

Japan Compliance & Regulatory Affairs Division Monitoring Resume Examples & Samples

Conduct electronic (email, Bloomberg, telephone) surveillance according to a structured program over the activities of defined business areas
Escalate, review and ensure appropriate follow up and documentation of potential red flags/ irregular findings
Maintain Japan manuals and procedures in relation to the MSA function
Support the regional MSA team as required
Look to continuously improve the surveillance program, identify risks and contribute to the efficiency and effectiveness of the MSA function

Japan Compliance & Regulatory Affairs Division Private Bank Compliance Officer Resume Examples & Samples

Provide pro-active compliance oversight and support for the Private Banking business
Look to continuously enhance the Private Banking business compliance control framework and processes
Provide advice to the business on regulatory/ compliance issues with respect to launch, offering, structuring and distribution of all asset classes and services (with a particular focus on funds)
Conducting proactive monitoring over the activities of the business first line of defense functions as well as conducting routine surveillance and reviews
Review and approve product / service related materials such as marketing materials, term sheets, presentations and product brochures
Draft and promulgate policies on product compliance, suitability, selling practices, risk disclosures etc
Backup other team members and provide support to the team if required

Japan Compliance & Regulatory Affairs Division Financial Crime Compliance Officer Resume Examples & Samples

Review new account opening applications to ensure that documentation is complete, and know your client due diligence standards have been met. Further, to conduct screening and anti-social forces checks on all connected parties
Policies and Procedures: Ensure that all AML relevant legislative and regulatory changes are duly captured and incorporated into local policies and procedures
Look to continuously enhance the AML program and related compliance control framework and processes
Conduct training and contribute to periodic risk assessments and other internal reviews and processes
Backup other team members and provide support to the team if required

Japan Compliance & Regulatory Affairs Division Financial Crime Compliance Officer Resume Examples & Samples

Head of Japan Financial Crime Compliance function, managing a small team of people
AML Advisory: Provide AML compliance advice to the business and support functions on AML and CFT laws, rules and regulations as well as CS policies
Oversee Suspicious Transaction Reporting framework and AML monitoring program
Sanctions Risk Assessment: Ensure sanction risks including those escalated through payment filters are appropriated managed
Look to continuously enhance the AML/ CFT program and related compliance control framework and processes

VP Government & Regulatory Affairs Resume Examples & Samples

Provide guidance and support at all levels of Comcast management to ensure consistent and sound government and regulatory policy; as well as ensuring compliance with local, state and federal requirements and mandates in the Great Boston Region
Sets strategic direction and overall guidelines for franchise renewals, including financial calculations and parameters for renewals. Serves as escalation point for issues for complex and/or difficult franchise renewals, franchise transfers, and franchise non-compliance issues
Keep abreast of regulatory affairs activities of communications companies, outside groups and utilities in order to identify issues relevant to the company
Develop and maintain positive relationships and collaborations with key government representatives and regulators at the Federal, State and Local level, as well as key stakeholders
Lead teams that will help educate elected officials and the community at large as to Comcast strategies and new product and services
Coordination with Division and Corporate leads on other regulatory matters involving Comcast
Oversee all franchise renewals including managing.. efforts to ensure compliance with franchise obligations
Oversee team that maintains relationships with municipalities and monitor involvement of municipal consultants if needed
Oversee and lead all community investment initiatives for the region
Manage community investment budget
Development of long-term grassroots strategy to support Comcast's business priorities
Lead team that will promote Comcast's economic and community investments in the Greater Boston Region
Oversee Internet Essentials initiatives in GBR to ensure growth for the program
Actively seek relief of burdensome franchise obligations
Establish oneself as a trusted advisor to regional leadership
Represents internally and externally as a member of the Senior Leadership team

Corporate & Investment Bank Office of Regulatory Affairs Executive Director Resume Examples & Samples

Input and advice to senior executives in connection with regulatory projects, communications or other initiatives:Partner with the Compliance Regulatory Management team to identify significant interactions or trends in supervisory dialogue, and advise on appropriate strategies to anticipate and respond to emerging regulatory priorities. In particular, to support and promote the development of a coordinated approach to contact with regional regulators ex-UK
Quality assurance: Participate in regional and firmwide processes that are designed to ensure regulatory remediation projects are executed to a high standard and fulfil the letter and spirit of regulatory requirements. Work with lines of business and functions to develop remediation plans that are proportionate, achievable and meet these regulatory requirements
Governance:Working with the regional governance team within ORA and the Office of the Secretary, ensure relevant regulatory issues are escalated and communicated effectively to senior governance forums, including legal entity boards and regional management committees. Participate in other regional governance forums to identify emerging issues that may require dialogue or additional disclosure to regulators in EMEA
Project management:On an ad hoc basis, initiate, design and/or execute projects to meet specific regulatory requirements. These will typically be projects of strategic importance to the firm, may involve innovative or complex concepts, and/or relate to issues that cut across multiple lines of business or functions
Policy advocacy: On select policy initiatives that have elevated strategic importance to the Bank, work with ORA to evaluate the practical impact of these measures on the firm, and support ORA in advocacy efforts to enable regulators to meet their intended objectives and minimize unintended outcomes
7-10 years experience in regulation, whether working for a regulator or Compliance, with preferably a strong background in supervisory practices at the UK and other leading EU regulators
Strong fluency in either of prudential or conduct regulation, with sound familiarity with the other
Ease working across a range of complex issues; ability to learn new topics quickly, courage to ask questions
Ability to effectively engage senior leaders around the firm
Ability to clearly communicate and present information both orally and in writing

Regulatory Affairs Project Leader Resume Examples & Samples

Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches
Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
Defines data and information needed for regulatory approvals
Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
Provide Regulatory Affairs support during internal and external audits
Plans schedules for regulatory deliverables on a project and monitors project through completion
Assists in the development of best practices for Regulatory Affairs processes
Represents Regulatory Affairs on cross-functional project teams
Partners with other functions to define and obtain data to assist with regulatory submissions
Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products
Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives
Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (especially EU)
Ability to partner and influence key stakeholders on NPD and Lifecycle teams
Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear)
Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives
Knowledgeable in US, EU and International Regulations
BS with demonstrable industry experience or equivalent
Practical experience with the preparation and submissions for Class II and III medical devices
Knowledge of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred

Senior Officer Regulatory Affairs Nicotine Resume Examples & Samples

Provide regulatory guidance on NCPs in the markets of interest, as well as support local markets in the region in terms of submissions and enquiries from regulatory authorities
Participate in regulated cross-functional activities related to NCPs, including but not limited to: risk management, change management, labelling management, and post-marketing surveillance
Ensure the timely and accurate preparation, compilation, review and publishing of NCP regulatory dossiers in compliance with local regulatory requirements and PMI’s internal standards, in support of clinical studies, market-specific regulatory engagement activities, and marketing authorizations
Stay abreast of current and new legislation in the European Union. Follow and analyze the applicable regulatory requirements to provide input on all regulatory aspects of relevance
Contribute to the development and implementation of processes, systems and tools enabling effective regulatory documentation/content management
Establish strong relationships within RRP in order to ensure alignment between regulatory strategies, product development and assessment plans, and business goals

Senior Officer Regulatory Affairs Heated Tobacco Products Resume Examples & Samples

Work in coordination with the Manager Regulatory Affairs HTP to define and implement registration activities for PMI's Heated Tobacco Products (HTP) in defined region, according to PMI's development and launch plan
Be responsible for preparation, compilation, quality & scientific check and publishing of RRPs submissions for HTPs in compliance with regulatory guidance/requirements in the defined region and PMI internal standards. Ensure completeness and accuracy of submissions to regulatory authorities in support of assessment studies, market-specific regulatory engagement activities and existing marketing authorizations
Ensure compliance and maintenance of all product registrations for PMI's HTPs in the defined region throughout the whole life-cycle of the products
Stay abreast of current and new legislation in the defined region. Follow and analyze the applicable regulatory requirements in the region and contribute to the implementation of submission plans and strategies
Provide advice to the organization for all regulatory aspects which are of relevance to PMI's HTPs in the defined region
Contribute to the development and implementation of processes, systems and tools enabling effective regulatory documentation/content management and communication with/submission to regulators. Provide input to optimize processes to ensure the development and implementation of electronic systems for effective management of documentation, submissions and archives (Controlled document management system for R&D and Regulatory publishing system and tools)
Establish strong relationships within R&D and associated commercialization functions in order to ensure alignments between regulatory strategies, product development & assessment and business goals
Reduced Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking combustible cigarettes. PMI’s RRPs are in various stages of development, and we are conducting extensive and rigorous scientific studies to determine whether we can support claims for such products of reduced exposure to harmful and potentially harmful constituents in smoke, and ultimately claims of reduced disease risk, when compared to smoking combustible cigarettes. Before making any such claims, we will rigorously evaluate the full set of data from the relevant scientific studies to determine whether they substantiate reduced exposure or risk. Any such claims may also be subject to government review and approval, as is the case in the USA today

Regional Head Regulatory Affairs Resume Examples & Samples

Develop and lead registration strategies in the region to ensure timely registrations for RRP
Develop and lead the registration strategies as required for other novel products in the region
Ensure timelines for regulatory clearance for product launches and priorities in the region are met
Ensure on-going regulatory product compliance of the RRP portfolio marketed in the region
Provide regulatory oversight and support to Product Development and R&D efforts in the development across PMI’s RRP platforms by participating and leading regulatory input into cross-functional project teams
Effectively manage relationships with the Regulatory Affairs group within PMI and relationships with regulatory authorities, where necessary, to ensure PMI regulatory applications are strategically aligned with regulators’ expectations
Provide leadership to the central Regulatory Affairs function in defining and implementing the registration activities in support of product registrations
Recruit and develop and maintain high caliber regulatory professionals to support individual country RA activities
Reduced Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking combustible cigarettes. PMI’s RRPs are in various stages of development, and we are conducting extensive and rigorous scientific studies to determine whether we can support claims for such products of reduced exposure to harmful and potentially harmful constituents in smoke, and ultimately claims of reduced disease risk, when compared to smoking combustible cigarettes. Before making any such claims, we will rigorously evaluate the full set of data from the relevant scientific studies to determine whether they substantiate reduced exposure or risk. Any such claims may also be subject to government review and approval, as is the case in the USA today

Director of Regulatory Affairs Resume Examples & Samples

As a member of Global RA Leadership Team, this person will be responsible for understanding and integrating the Diversey Care strategic objectives with the Global RA Service Center and Regional teams work plans. This person is also responsible for ensuring that the necessary skill sets are available or developed within the RA group
Participates in division’s strategy meetings, showing ability to identify, assess and communicate regulatory constraints and trends, as well as risks and opportunities while integrating in Division’s strategy, timelines and budgets
Leads coordination of compliance projects for the portfolio
Identify, assess and ensure agreement on potential risks in division compliance strategy
Possesses practical working knowledge of the global regulations that affects Diversey Care. A non-exhaustive list includes: TSCA, EPA Regulated Substances, Cosmetic Products, GHS, CLP, EU BPR, REACH
Holds full responsibility in setting priorities and defining resource allocation and requirements, including ad-hoc support by the Global Service Center, and flags any issues early to the RA team and with Division leadership as appropriate
Accountable for defining the division’s global advocacy strategy (together with other RA Business Partners) and implementing with Regional Leaders and SMEs; leverage the RA resources to shape a favorable regulatory environment at all levels, showing ability to identify risks and opportunities on a global scale
Represents and promotes the company and the division in the global regulatory scenario, through leadership roles in sector’s associations such as the American Cleaning Institution. Also, will actively participate in international conferences
Develop insight with Regulatory Authorities, understand trends, effectively participate in wide regulatory strategies
Leverage personal and group’s competency to gain insight with key and prospective clients
Bachelor’s degree in Chemistry, Chemical Engineering, Microbiology or Science related field
Minimum five years’ experience in regulatory affairs, preferably in the chemicals area, with demonstrated successful work history
Experience of working in global environment
Fluent in the English language, second language preferred
Strong communication and interpersonal skills, including solid presentation skills
Proficiency in Microsoft Office applications

Scientist Regulatory Affairs Resume Examples & Samples

Ensure regulatory compliance of products, labels, advertising and promotions as well as adherence to policies and guidelines
Develop nutrition and regulatory technical information for ingredients and products
Review/approve label graphics for regulatory compliance and technical accuracy
Review advertising and promotional materials for technical accuracy and compliance
Provide nutrition and regulatory guidance on project teams to enable accurate decision-making
Partner with R&D and business teams to identify opportunities for the brands
Stay abreast of nutrition and regulatory developments and identify opportunities and implications to the business
Manage and elevate consumer inquiries and support corporate requests

Regulatory Affairs Operations Officer Resume Examples & Samples

Working knowledge of theories, principles and concepts typically acquired working in a clinical research setting, academic research, or health care environment related to research administration
Understanding of research compliance and Human Research Protection Programs, or research regulations preferred
Excellent verbal communication skills and writing skills
Demonstrated experience working with multiple internal and external constituencies to build consensus in setting agendas and implementing approaches in large decentralized setting
Proactive, time-sensitive, results-driven approach to carrying out assigned and assumed responsibilities, and possess the ability to handle multiple, often competing tasks, with grace and good humor to reach common group goals
Flexibility and adaptability to changing priorities
Comfort with public speaking
Familiarity with REDCap, Qualtrics or other survey tools a plus

Regulatory Affairs & Quality Associate Resume Examples & Samples

Responsible for compliance with applicable Corporate and Divisional Policies and procedures, including local and international regulations applicable to clinical trials supply chain activities
Maintain a good understanding of local and international regulations, and keeping abreast with regulatory changes and developments
Provide consultative guidance on regulatory matters to clients and internal associates
Responsible for liasons with local and international regulatory bodies
Coordinate regulatory and submission activities for the following: importation/exportation of investigational medicinal products (biologicals/controlled substances/psychotropics/cytotoxics)/medical devices, local clinical trial import licences, GMP and GDP Certificates and related approvals/licences
Maintain and updates all regulatory licences/certificates/approvals and related regulatory databases
To ensure that the inventory of supplies is accurately maintained with supporting documentation
Responsible for comparator drugs and ancillaries sourcing
Manage and coordinate all recall activities (internal/client initiated/regulatory initiated)
Prepare new and update existing job related Standard Operating Procedures (SOPs)
Perform pre and post review and approval of production batch records
Perform pre and post review and approval of label printing records In-process inspection responsibilities for production and label printing jobs
Assist in the QA/GMP training of employees across the company
Participate in department systems development initiatives to improve regulatory and quality efficiency and compliance
Perform ad-hoc duties as requested by line management
Previous working knowledge in the pharmaceutical/medical/healthcare settings in the field of quality assurance and regulatory affairs

Regulatory Affairs Office, Director Resume Examples & Samples

End-to-end regulatory exam management, including JFSA and BOJ Proactive open issue tracking (MRA/MRIAs) and issue escalation
Regulatory change management and reach-out
Manage annual roll-up of MUFG and BTMU by primary regulators
Communicate continuously with Tokyo HO stakeholders, including but not limited to BTMU Global Planning Division and MUFG Government and Regulatory Affairs Office
Manage and coordinate senior executive communications with regulators
Build relationship with all primary regulators at the senior level, including those with DC staff functions
At least 10 years’ experience in diverse business roles – e.g., revenue generating roles, program management, audit/compliance, managing staff functions

Regulatory Affairs Leader Resume Examples & Samples

Work closely with other professionals across the company to ensure compliance to global regulations and reporting requirements related to post market surveillance
Identify complaints that meet the global definition for reporting and facilitate the timely submission of regulatory reports
Determine the need for, prepare and, when required, submit regulatory notifications including adverse events, accidental radiation occurrences and notifications of defect or failure to comply
Complete reportability assessments
Provide input for evaluation of potentially hazardous/potentially reportable complaints; review potentially hazardous complaint files to ensure
Bachelor’s Degree & minimum of 3 years experience in the medical device industry or
Demonstrated experience operating in a highly regulated environment; proven application of analytic skills in a regulatory environment
Knowledge of the FDA’s Quality System Regulations; experience working within a Quality Management System
Ability to prioritize, plan & evaluate deliverables to established strategic goals
Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
Strong problem solving, influencing and negotiation skills
Ability to work well independently & in a team setting
Prior experience using spreadsheet and presentation software
Strong working knowledge of Medical Device regulations, such as FDA CFR 21 Parts 820, 803, 806 & 1002/03; ISO 13485; MDD; CMDR
Regulatory Affairs Certification (RAPS)
Experience with ISO 14971 (Risk Management)
Experience with IEC 60601, 2nd Edition (if involved with electro-mechanical equipment)
Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL
Experience with working across cultures/countries/sites
Demonstrated ability to identify, influence and lead process improvements and procedural changes
Proven experience in Nuclear Medicine medical devices

Regulatory Affairs & Product Stewardship Manager Resume Examples & Samples

Propose regulatory submission strategies and achieve Product Stewardship Chemical Inventory Listing in support of the business strategy
Create and maintain Product Stewardship records relating to company products, intermediates and raw materials
Responsible for the continuing integration of Product Stewardship into business and R&D processes
Responsible for gaining and maintaining agency listings as directed by business management
Ensure compliance with global regulations i.e. REACH, GHS, etc
Respond to internal and external requests for product safety information on company products
Interact extensively with internal and external customers both domestic and international
Prepare and revise SDS, labels and other hazard communication information using a SAP
Provide broad technical expertise in OSHA, FDA, ISO 10993, and other global substance control regulations
Keep abreast of and assess international chemical control laws and pending regulatory developments through reference sources
TSCA Coordinator for the business, oversee TSCA compliance, lead investigations regarding TSCA 8c/8e allegations of health and safety issues related to the use of our products or raw materials
Special projects and other duties as assigned by management
Conduct assessments and ensure proper implementation of Responsible Care for the Product Safety Code and other Solvay Product Stewardship Management Systems
Individual contributor and also Manager of the Aromatics Product Stewardship team

Regulatory Affairs & Quality Consulting Manager Resume Examples & Samples

7+ years of experience in regulatory affairs and quality within the medical device industry
7+ years of experience in medical device quality engineering with a background in manufacturing engineering and/or process engineering, ASQ/CQE, preferred
Bachelor’s degree in Science, Engineering or related field, preferred
Expert knowledge in FDCA, FDA QSR, EU MDD, and ISO 13485 requirements
Working knowledge of ISO 14971, IEC 62304 and IEC 60601 series standards, preferred
Experience to include but not limited to: QS SOP development, PHA / risk management, and design control best practices to ensure compliant DHF, V&V, DMR transfers, working knowledge of FDA requirements for internal / supplier audits and FDA inspections and continuous improvement methodologies
Frequent travel throughout the region, with approximately 75% overnight travel

Regulatory Affairs Operations Coordinator Resume Examples & Samples

Manage the Director’s complex calendar and related logistics by triaging a high volume of scheduling, travel arrangements, expense reporting and related logistics to assure the Director and Program meets deadlines and deliverables
Assist the Director in developing agendas for high-level meetings and attend meetings as requested to take minutes and capture action items
Review, redline, and proofread documents such as reports, agreements and presentations
Draft high-level correspondence such as email, and other communications
Create PowerPoint presentations with infographics for local and national presentations
Collect Program metrics with assistance of the Regulatory Officers
Assist the Director and Associate Director in maintaining the Regulatory Internship Program by assisting in assessment and prioritization of administrative tasks, intern tasks, and calendar coordination
3 or more years providing administrative or executive support and project coordination, preferably in the area of research administration, academia, or healthcare
College degree preferred or an equivalent of education plus experience in an office environment
Successful candidates will have well developed interpersonal and communication skills with experience providing complex administrative support in a high profile, very fluid environment, with tact and diplomacy on a range of issues, many of which are confidential in nature
Ability to work with cross-institutional teams and with a variety of special/ongoing projects and diverse constituencies
Excellent organizational and writing skills
Excellent computer skills, including knowledge of Microsoft Office and Outlook, and PowerPoint
Ability to prioritize work in an environment with multiple and conflicting interests
Expertise with scheduling/calendaring coordination
Paralegal experience a plus

VP, Regulatory Affairs & Compliance Resume Examples & Samples

Drive compliance program growth & maturity across US Pharma
Lead the compliance program growth & maturity across Regulatory Affairs (other than for controlled substances regulatory compliance matters which is managed by a separate team) and Compliance & Ethics for US Pharma. Identify and leverage synergies across both groups as these two teams will be newly combined
Effective training and education, such as policies and procedures
Effective lines of communication
Internal monitoring and auditing of US Pharma business units operations
Compliance risk assessments
Effective controls and metrics that enable management to conduct operations in a manner that will meet compliance obligations
Work with HR and employee relations teams to ensure well-publicized disciplinary policies and guidelines that will enable management to consistently enforce standards
Rapid response process to enable management to respond to detected problems and undertake corrective action
Support internal investigations efforts conducted by Global Compliance & Ethics CE team and lead investigations assigned to the BU Compliance teams in response to reports of possible compliance violations, including communication with management to alter operational procedures and/or service/product changes to decrease the likelihood and severity of any future offenses
Encourage when appropriate corrective action as a result of internal investigation with all departments, providers, and employees
Successfully manage a team of 7 to 8 Regulatory Affairs & Compliance & Ethics professionals
Develop a combined function that leverages synergies across both groups
Act as the key US Pharma liaison and collaborator with Global Compliance & Ethics and manage the implementation of enterprise-wide compliance initiatives
Compliance work experience within a Regulated industry or within the Healthcare industry working with Hospitals, Pharmaceutical Manufacturers and/or Pharmacies
Excellent oral and written communications skills, analytical skills and advanced knowledge of the law
Practical experience in writing and implementing policies and procedures
Strong influencing and partnership skills
In depth knowledge of compliance and ethics frameworks and principles, and experience in compliance programs based in US Federal, state, and/or international laws
Excellent oral and written presentation skills, including the ability to communicate to all organizational levels
Demonstrated excellence in leadership, alignment and execution
Demonstrated ability to successfully influence across many organizations at all levels
Demonstrated experience in working collaboratively in cross-functional and cross- divisional teams or solving cross-functional/cross-divisional issues in a manner that not only demonstrates both strategic and tactical thinking, but also in a manner that builds, maintains, and enhances a positive working relationship
Ability to recruit, train, coach and retain team members
Ability to tolerate ambiguity and to remain flexible under pressure

Regulatory Affairs Consultant Medicare & Retirement Resume Examples & Samples

Manages and is accountable for own workload
Impact of work is most often at the national product level
Supports Medicare and Medicaid Product teams’ direction, resolves problems and provides guidance to business partners
May oversee work activities of others
Adapts departmental plans and priorities to address business and operational challenges
Influences or provides input to business product forecasting and planning activities
Product or process decisions are most likely to impact multiple groups of employees and/or customers (internal or external)
Collaborate with product teams to review, analyze, and develop / oversee initial implementation project plans to support business implementation with new or existing laws and regulations
Track and analyze all new regulatory requirements pertaining to Medicare, dual products, Medicare-Medicaid, lines of business
Develop knowledge of Medicare STAR Ratings methodology and annual cycle to support business partners in their assessment and implementation plans
Develop knowledge of Special Needs Plans Model of Care requirements to support business partners in their annual submissions
Develop relationship with the SNP Alliance and share industry information with internal partners
Prepare summaries of analysis that include, as appropriate, relevant legislative history, comparisons to existing or proposed legislation in other jurisdictions and detailed descriptions of the operational requirements and affected functions
Develop and provide training of regulatory requirement
5+ years of experience in a health care regulatory environment
3+ years project management experience, including experience simultaneously managing multiple projects
Working knowledge of Medicare and Medicaid, STARS, CMS guidance on Special Needs Plans
2+ years of experience working with Federal Government Programs
Excellent communication skills, verbally and in writing
Ability to analyze and problem solve with a high degree of accuracy and attention to detail
Managed care, and/or compliance expertise
Ability to effectively understand and communicate detailed and complex information verbally with others, including government officials and senior leadership
Superior planning and strong problem solving skills that enable quick identification and efficient resolution of issues
Highly collaborative individual with ability to influence others and build strong professional relationships

Head of Cosmetics Safety & Regulatory Affairs Scientist Resume Examples & Samples

Regulatory strategy and product management relating to EU cosmetic regulation EC 1223/2009
Providing scientific advice to clients and colleagues on European and US regulatory requirements
Developing and leading a successful team
Growing existing client base for cosmetics safety and regulatory affairs including identifying additional business development opportunities
Ensuring that projects are delivered to high standards, on time and within agreed budget
Producing Product Information Files (PIFs) and Cosmetic Product Safety Reports (CPSRs)
Accountable for managing our Responsible Person (RP) duties on behalf of our international clients
Minimum of BSc in chemistry, pharmacology, biology, cosmetic science or a closely related field together with experience of working in a technical/regulatory environment
A proven track record of managing regulatory data and communicating technical data to a non-technical client base
Thorough understanding of the EU and US cosmetic regulations
Business development and staff management experience
A team player who can lead projects and who works well with colleagues and clients

Analyst, Regulatory Affairs Resume Examples & Samples

BCII Regulatory affairs expert – responsible for
Compilation of documentation and liaison with Corporate RA & Subcommittees in respect of activities required for
Adverse event review and agency reporting
Issuing Product Information Notifications/Field Safety Notice/Product Corrective Action letters
Device modification proposals for review by Corporate RA
Compilation of global regulatory submissions
Co-ordination of the licenses for controlled substances and other documentation as required from the Dept. of Health & Children and Dept. of Agriculture
Implement regulatory/quality system requirements as per IVD Directive (CE Mark) ISO13485 and FDA QSRs
Control of distribution of product from regulatory perspective through regulatory stop ship program
Provision of Regulatory affairs advice when requested internally and from interpartners
Participation in BCII Internal and External Quality Audit as required
Participation in BCII Risk Management & Design Control processes from a regulatory perspective as required
Participation in Management Reviews of the Quality & Environment System as required
Communication to management on Regulatory affairs issues, which require addressing
Approval of Printed material from a regulatory affairs perspective
CE Marking – Regulatory requirements (ref. CE Technical Files)
Dealing with European Competent Authorities as needed regarding vigilance and registration
Will be qualified to a minimum of B.Sc. level in a Scientific field or other relevant technical field
Have a minimum of 1 year experience in a QA or RA role within a manufacturing facility
Excellent written and communication skills are essential, which will result in strong working relationships cross functionally within BCII
Ability to work in a very busy environment, ability to manage change effectively in order to better serve our internal customers, external customers and legislative demands
Knowledge and understanding of the IVDD Directive and the associated harmonised standards
Knowledge and understanding of ISO13485: 2003 and the FDA QSRs
Experience of 510K preparation and submission process for FDA pre-market approvals is desirable
Experience of product registration process for countries other than EU and USA is desirable
Experience of internal auditing is desirable

Regulatory Affairs Administrator Resume Examples & Samples

Compilation of documentation required for global regulatory submissions
Compilation of documentation as required by Corporate RA
Dealing with regulatory enquiries from inter-partners and internal customers
Co-ordination of the licenses for controlled substances and other documentation as required from the Dept. of Health & Children and Dept. of Agriculture
Control of distribution of product from regulatory perspective through regulatory stop ship program
Participation in BCII Internal and External Quality Audit as required
Communication to management on Regulatory affairs issues, which require addressing
Approval of Printed material from a regulatory affairs perspective
Compilation and update of CE Technical Files
Routine departmental office duties including ordering, filing, maintaining logs, issuing reports, etc
Good administrative experience
Very good knowledge of Microsoft Word and Excel
Knowledge of Quality Standards/GMP
Third level science qualification, or relevant experience in an FDA regulated environment a distinct advantage

Team Lead Regulatory Affairs Digital Dentistry Resume Examples & Samples

Development and execution of regulatory strategies for development projects within the Digital Dentistry business unit
Leading the RA team for software and individualized prosthetic development and registration in the early markets (US; EU; CAN, AUS)
Responsible for monitoring submissions and timely execution of projects
Mentoring the RA team
Support of product development in cross functional teams
Review and/or approval of documents of the design control process
Accountable for regulatory compliance
Support international product registration
Assessment, approval and regulatory implementation of change requests
Review and approval of product related labeling and marketing material
Support SAP based reporting systems
Develop and maintain standard procedures for RA relevant processes
Monitoring legislative environment in relevant markets
Training internally on relevant procedures and requirements
Technical or scientific background, university degree is an advantage
Minimum 5 years experience in Regulatory Affairs within the Medical Device Industry
Experience with EU, US, AUS and CAN medical Device regulations
Experience in preparation and support of notified body audits and FDA inspections
Experience in managing cross functional projects and teams
Excellent Knowledge of medical device legislation EU ,US, AUS and CAN and corresponding guidelines
Excellent knowledge of product development processes in MD industry
In depth knowledge of requirements for software development and registration as Medical Devices (IEC 62304 and ICE 62366) as well as standards for electrical products such as IEC 60601
In depth knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
Fluent in English (verbal & written), further languages are an advantage
Highly organized and able to work under strict time lines
Strong interpersonal skills and proactive working attitude in a international matrix organization

Senior Analyst Regulatory Affairs Resume Examples & Samples

Represent Global Regulatory Affairs on all matters relating to global processes
Manage and maintain UDI labeling project and associated performance metrics
Participate in Product Labeling Council with support in developing the meeting agenda and presenting the selected subjects as appropriate
Participate in Global Regulatory Council with agenda items, review of new regulations, guidance documents, and standards with ability to conduct impact assessment , present clearly, and gain consensus for decision and adoption as necessary
Liaise with the regional and geographical Q&RA organization to support and ensure alignment with BEC global policies and procedures
Support the continual growth and development of the Global Product Registration System (Trackwise)
Continually develop, monitor and report on the metrics needed to gauge the performance of the Global Product Registration System
Review and update as necessary changes to existing processes and SOPs as defined by changes in regulations and standards
Support the application of Danaher Business System (DBS) tools throughout Global Regulatory Affairs and drive DBS activity throughout the global processes
Review changes to existing products and SOPs to define the requirements for regulatory submissions
Maintain current knowledge of FDA and international regulations, guidance documents and standards applicable to company products
Actively participate in evaluation of regulatory compliance of document / product /process /test methods changes
Participate in research of regulatory issues and dissemination of regulatory information to the various departments and senior management as required
Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
Works with minimal guidance and expands knowledge and skill sets beyond own area
Supervise Regulatory Affairs consultants and/or interns as required
Bachelor’s degree in field with 5+ years of experience or Master’s degree in field with 3+ years exp. Or Doctoral degree with 0-2 years exp
Hands-on product registrations experience for the USFDA and ex-US countries strongly preferred

Quality Assurance & Regulatory Affairs Senior Manager Resume Examples & Samples

Manage the QRA staff and activities supporting the LBS Companion Diagnostics business
Responsibilities include but are not limited to development of regulatory strategies to meet regulatory requirements, project and business goals. Will also manage the organization, planning and compilation of regulatory submissions and associated activities of team
Responsible for overseeing the maintenance and compliance of the LBS Companion Diagnostics quality system in the Danvers, MA facility. Also responsible for ensuring all CDx projects are aligned with the quality systems of other LBS locations and third parties, as applicable
Work closely with members of LBS global regulatory team to coordinate the development of regulatory strategies to meet business needs. As needed, manage or support the creation and submission of international filings
Responsible for managing staff performance and development according to Danaher standards and local practices
Serve as a contact with the US FDA and other government officials while representing LBS for submission reviews, face-to-face meetings, teleconferences and written communications
Serve as official QRA management representative for LBS Danvers location
Serve as a contact with pharmaceutical companies representing LBS QRA interests and requirements on CDx projects. Will also represent LBS QRA during capabilities presentations and other activities related to gaining CDx business
Manage QRA timelines, budgets and resource allocation according to requirements of CDx business team
Use Danaher Business System (DBS) tools to lead team and QRA function in continuous improvement initiatives
Bachelor’s degree in life science, medical or biotechnology field and relevant experience with increasing responsibility in medical device regulatory affairs, or
Graduate degree in life science, medical or biotechnology field and relevant experience with increasing responsibility in medical device regulatory affairs
Related experience includes relevant people management experience
Experience in the IVD field preferred and CDx experience very beneficial
Must have requisite training or certification in medical device regulatory affairs through on-the-job training, seminars, training. RAC certification preferred
Must have experience managing medical device quality systems in compliance with US FDA regulations (21 CFR) and ISO 13485. Quality system or auditing certifications highly desirable
Experience with successful clearance and/or approval of US FDA medical device submissions (e.g. 510k, PMA, BLA)
In-depth knowledge of global medical device regulations in established and high growth markets (e.g. US FDA, IVDD, Japan, China, Brazil)

Regulatory Affairs Esubmission Manager Resume Examples & Samples

Support the development of compliant regulatory electronic/IT systems
Liaise with global and country Regulatory Managers on how to build and maintain electronic submissions
Work with the Regulatory Agencies and Regulatory Affairs authors to ensure that documents comply with regulatory and company guidance specifications
Work with all departments to implement, maintain and train processes and quality control checks to ensure electronic submissions are complete and meet technical, eCTD regulatory requirements, guidelines, internal standards and timelines
Assess the impact of eCTD-related software upgrades and changes. Interface with IT and other regulatory departments to ensure a smooth transition and perform trainings to other users as applicable
Maintain regulatory archiving systems and regulatory databases
Be updated on ICH/ROW specifications and specific national regulatory esubmission guidance and legislation
Education: University degree (min. Bachelor) in either IT, economical or in natural science such as pharmacy, biology, chemistry
Languages: English (fluent) / German (basics)
Personality & Experience: High affinity for IT systems and willingness to acquire specific knowledge about electronic transfer and technical requirements within regulatory affairs within the pharmaceutical industry. (Ideally) experience in Regulatory Operations with a focus on electronic submissions and/or understanding of different functional document types that comprise regulatory submissions. Sound organizing skills and ability to handle several activities at the same time; Ideally experience in either IT-Management/Projects or within Regulatory Affairs; Good leadership and training skills for leading crossfunctional teams

Specialist, Regulatory Affairs Resume Examples & Samples

Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA Annual Report, Shonin, PLA, CE-Mark Design Dossier, CEMark Technical File, Intercontinental Dossiers, Certificates to Foreign Government
Ensures that existing approvals and documentation are maintained, including SAP Foreign Trade Status. Communicates with in-country RA personnel to facilitate global clearances/approvals
Under the direct supervision of RA Project Manager or RA Department Manager, develops global regulatory strategies for project teams
Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies
Monitors, researches and obtains information [via FOI] on FDA clearances/approvals of competitors, and proactively shares this information with interested parties
Communicates with regulatory agencies under direct supervision of the RA Project Manager or RA Department Manager
Assume regulatory review of labeling content, product and process changes and product documentation
Excellent writing and verbal communication skills and experience working on cross-functional project teams
Basic working knowledge of all U.S. regulations that affect Class II devices
Basic understanding of global regulations
Strong problem-solving and analytical ability
Familiarity with new product development systems
Required computer skills include intermediate to advanced Microsoft Word and beginning to intermediate Microsoft Excel
Comfortable working in a variety of corporate business management computer systems
A Bachelor of Science degree in a scientific or engineering discipline is required; a Masters degree preferred

Regulatory Affairs & Quality Assurance Supervisor Resume Examples & Samples

3+ yrs experience in Regulatory Affairs & Quality Assurance
Working experience of country regulatory affairs regulations and processes
Working experience in Class III & IV submissions
Advanced proficiency in English and required (reading, writing and speaking)
Strong proficiency in MS Office, including PowerPoint, Excel, Word and Outlook
Excellent organizational skills and demonstrated ability to handle multiple tasks accurately and efficiently
Prior experience in fast-paced office with multiple priorities
Must be customer service oriented with strong interpersonal skills
Excellent presentations skills
Responsive, action-oriented and innovative problem solver
Experience preparing international product registration dossiers
Experience compiling technical files
Regulatory/clinical/product development/ quality experience

Regulatory Affairs Consultant Resume Examples & Samples

Undergraduate degree
3+ years of experience in a legal or regulatory environment
Proficiency with MS Office (i.e. Excel, PowerPoint, etc.)
Healthcare regulatory environment and/or managed care experience

Quality Assurance / Regulatory Affairs Intern Resume Examples & Samples

Completed at least one year of college education before beginning internship
Must be enrolled in school the semester following your internship
Pursuing a Bachelors or Masters Degree
Authorized to work in the United States without requiring sponsorship
Must be geographically mobile
Strong academic performance (GPA = 3.0/4.0)
Exceptionally demonstrated interpersonal skills
Demonstrated oral and written communication skills
Quality: Pursuing Biology, Biochemistry, Chemistry, Bioengineering Degree

Regulatory Affairs Advertising & Promotion Manager Resume Examples & Samples

Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Submission/registration types and requirements
Good practices (GxP's)
Principles and requirements of promotion, advertising and labeling
International treaties and regional, national, local and territorial trade requirements, agreements and considerations
Domestic and international regulatory guidelines, policies and regulations
Ethical guidelines of the regulatory profession, clinical research and regulatory proces

Contract Role-regulatory Affairs Resume Examples & Samples

BA/BS degree in a scientific/health sciences discipline
5 years of experience in regulatory affairs in the pharmaceutical/biotech industry
Solid understanding of the processes and interactions essential for the production of regulatory submissions
Experience with US and ex-US regulatory submissions, including: eCTD, IND, CTA, NDA, orphan drug, fast track, SPA and additional submission types
Must be “hands-on” and willing and expected to take on projects and tasks to support the team
Able to implement and manage projects

Manager of CMC Regulatory Affairs Resume Examples & Samples

Planning and preparing CMC documentation for U.S. IND submissions, amendments, and annual reports
Planning and preparing CMC documentation for CTA submissions and amendments for Canada, Europe and other countries
Reviewing IND/CTA CMC documents including response to inquiries from health authorities, and preparing them if necessary
Collaborating with AIRM contract manufacturing organization(s) on CMC related matters
Participating in planning (including document authoring and review) and execution (including attendance, if appropriate) of FDA meetings on AIRM projects, and providing support for these regulatory activities
Providing guidance and support to AIRM staff regarding global CMC regulatory matters
Establishing, promoting, enhancing and maintaining effective collaborations in global CMC activities among AIRM, Astellas-US, Astellas-EU and API
Supporting the update or creation of regulatory affairs SOPs
Obtaining appropriate information and advice from outside consultant(s) for creating CMC regulatory strategy both general and to address specific topics
Researching and disseminating regulatory intelligence on trends in US regulatory affairs in the CMC area for biologics and industry standards for CMC regulatory work
Participating in AIRM and Astellas Development meetings, as appropriate
Bachelor's degree in Life Sciences
A minimum of 5+ years experience in regulatory affairs and other relevant experience in pharmaceutical development of investigational stage drug/biologic products
Adequate knowledge of US, Canada and EU CMC regulations as well as ICH and US guidance documents related to CMC matters and strong knowledge of process, formulation or analytical chemistry for biologic products
Ability to manage multiple projects/submissions concurrently
Strong leadership, interpersonal skills and the ability to work in a project team environment

Regulatory Affairs Senior Associate Resume Examples & Samples

Labeling
Assist in establishing a labeling development process for company products
Manage required label updates, proofreading of labels, and version control
Work with Regulatory Operations to facilitate conversion of label to structured product labeling (SPL) and updating SPL as needed for CMC and labeling changes
Post correct labels to company websites
Maintain tools that support coordination with other functions (e.g., Marketing) to ensure only agency approved labels are produced for appropriate products
Maintain and catalog all labeling materials in accordance with company policies, procedures, and technologies
Advertising and Promotion

Regulatory Affairs Director Resume Examples & Samples

Provide regulatory leadership and guidance to the marketing team during the development, review and approval of product labeling and advertising materials
Assist the Sr. Director of Regulatory Services in regulatory oversight related to advertising and promotional activities within Mallinckrodt
Work directly with each of the marketing teams from concept through review and approval, up to and including DDMAC/OPDP submissions
Provide a leadership role on the promotional review committee (PRC) for regulatory review of all product labeling and advertising materials
Work collaboratively with Compliance to ensure that materials approved by PRC are used within the intended guidelines
Work with the Sr. Director of Regulatory Services to review and approve non-promotional items such internal training documents and internal communications
Represent the company to outside customers and agencies and make presentations as needed on current regulatory issues pertaining to Advertising and Promotional activities
Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives
Interact effectively with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that timelines are met
Provide oversight of regulatory document control activities
Work collaboratively with medical and scientific personnel on development and review of materials related to advertising and promotion
Participate in training of sales and marketing personnel on promotional, marketing, labeling and advertising regulations
Serve as a FDA liaison for matters related to advertising and promotion
Work with other regulatory team members to provide input into improvement of systems and/or processes
Provide insight into current directions in the regulatory environment, such as updates on warning letters, FDA meetings etc
Review current policies and practices issued by Federal regulatory agencies and update management as needed
Review regulatory guidelines and publications to keep apprised of new regulatory developments
Receive project assignments from supervisor but has responsibility for managing timelines for projects with minimal supervision
Provide regulatory-based recommendations on marketing project initiatives and make recommendations for improvements for existing projects
At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee
At least three (3) years in a team leadership role with highly effective people management skills
Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities
Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills
Proven ability to prioritize and meet project deadlines
Ability to determine essential components of requirements in order to include them in applicable policies and procedures

Associate Director, CMC Regulatory Affairs Resume Examples & Samples

Manage timelines in cooperation with project management, Operations, SMEs and Tarrytown Regulatory Operations (RegOps) to ensure on time regulatory submissions
Assist with the planning, scientific writing and perform critical reviews of preINDs, INDs, IMPDs. BLAs, MAAs, annual reports, DSUR, amendments, supplements to ensure a high quality regulatory submission and approval
Ensure that all regulatory submissions are of highest regulatory standards
Coordinate and manage regulatory inspections, as needed, at the Rensselaer site or at other sites if the inspection relates to regulatory CMC issues
Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAslMAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements
Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field
Assist in tracking of CMC regulatory commitments for INDsIIMPDs, CTAs, and BLAslMAAs
Participate, as needed, in planning, organizing and managing the CMC component of pre-IND and pre"BLA meetings with FDA
Support Ops by providing CMC related guidances so that their short-term and long-term goals are achieved on time and with highest quality
Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests
Requires a Ph.D. or M.S. degree in a science related discipline and a minimum of 10 years pharmaceutical industry experience and 6 years of relevant CMC biotech/pharmaceutical industry experience

Head Regulatory Affairs Resume Examples & Samples

University degree in Chemistry, Biochemistry, Pharmacy
Minimum of 10 years in the pharmaceutical industry with knowledge in Regulatory Affairs. #LI-SA
Fluent in English
Background in active ingredient production, analytics and registration regulations. #LI-GZ

Regulatory Affairs Documentation Specialist Resume Examples & Samples

Provide support to Regulatory Affairs Specialist(RAS) and Regulatory Affairs Manager (RAM) in preparation of regulatory submissions & pending dossiers
BS degree in a relevant discipline
Special Skills: Team player with excellent interpersonal skills; known to be well organized, with an eye for detail, strong IT skills and good cross-cultural awareness. Recognizes sensitive & confidential status of information & handles accordingly
Knowledge: Technical skills: computer literate (Email, Word, Excel, Internet, …)
Languages: Multi-lingual: Fluency in English and good knowledge of local country language (Dutch and/or French) as pre-requisites; other European languages as assets
Writing skills: ability to write proficiently in English
Oral skills: ability to speak proficiently in English

Biotech Regulatory Affairs Oilseeds Team Lead Resume Examples & Samples

Provide leadership to US Biotech RA Oilseeds Team preparing U.S. regulatory submissions, delivering U.S. regulatory approvals
Lead the development and delivery of global regulatory strategies for Monsanto's oilseeds products in collaboration with colleagues in the global Regulatory organization to obtain regulatory approvals in key export and production countries
Attract, integrate, motivate, develop, and assess talent in the US Biotechnology Regulatory Affairs Oilseeds team to maximize each employee’s contribution and potential to grow and contribute to Monsanto’s future success
Collaborate closely with other Leads and teams within US Biotech RA and globally to ensure development of integrated U.S. and global regulatory approval strategies for biotechnology products across platforms and contribute to strategies across the entire biotech product portfolio, consistent with the broader context of the Regulatory mission and specific business plans
Lead collaborations with the business teams on the identification, implementation, and management of regulatory acceptance and stewardship issues for oilseeds

Biotech Regulatory Affairs Cross Crop Strategy Manager Resume Examples & Samples

Support the delivery of global regulatory submission strategies for Monsanto's biotech products in collaboration with colleagues in the global Regulatory organization and coordinate the interaction and support between global teams and US Regulatory Affairs
Provide leadership and build effective relationships with specific country teams to ensure effective communication and information flow with key stakeholders, effective issue resolution across the product portfolio and facilitate collaboration across multiple global teams
Collaborate with the product specific Regulatory Affairs Managers to provide input and guidance on regulatory submissions to ensure that appropriate national (e.g., USDA, EPA, FDA) and international data (e.g., CODEX, OECD) requirements are met consistently across different products in all global regions
Help prepare regulatory submissions, monitor and coordinate resolution of challenges that may impact other portfolio products and responses to questions from regulatory authorities, and develop other related documents and processes (e.g., dossier templates, position statements, etc.) to obtain regulatory approvals in key export and production countries
BS, MS or Ph.D. in Molecular Biology, Crop Science, Genetics, Plant Breeding, Plant Pathology, Biochemistry, Protein Chemistry, Toxicology or related scientific discipline
5+ (BS), 2+ (MS/PhD) years relevant experience in the agricultural, biotechnology, pharmaceutical or related scientific based industry
Excellent written/oral communication and organization skills are required
Ability to think broadly to identify cross-cutting challenges and their impact on Monsanto’s product portfolio
Ability to successfully interact with a wide diversity of people and establish effective relationships and networks
Experience and/or an understanding of regulatory processes for biotechnology products and interactions with key global regulatory governing bodies/agencies
Experience working on global teams and communicating cross-culturally
Experience with process improvement and project management tools
Fluency in one or more languages, in addition to English, would be a plus

Manager, International Regulatory Affairs Resume Examples & Samples

Contributes to development of submission strategy for projects assigned
Provides input to project teams during the development of regulatory plans & filing strategy to ensure acceptable labelling in markets assigned
Establish within country, cross-product submission plan in association with Global/Regional Regulatory Lead, Regulatory CMC, commercial, affiliates &/or marketing partners
Creates Content Plans to allow publishing & timely dossier submission
Responsible for building quality regulatory dossiers. Works with other functions as necessary
Act as contact person in RA EMEA for local partners & affiliates as required
Lead the organisation in the preparation of answers to questions from regulatory authorities
Responsible for ensuring that Celgene fulfils Regulatory Authority commitments
Ability to lead complex regulatory submissions for assigned projects
Responsible for tracking all activities & for accurate submission plans in eQRMS and communicating any emerging issues to stake holders in a timely manner
Ensures that copies of regulatory documents are archived appropriately
Proposes process improvements to manager. Shares best practice involving International regulatory submissions
Good understanding of high level strategic issues & implications of Company Core Data Sheet & Regulatory CMC
MOEU
Bachelor’s degree in a scientific discipline or equivalent
Experience of leading International Regulatory Affairs (RA) submissions
Strong understanding of International regulatory landscape & required approaches/strategies
In-depth knowledge of regulatory requirements for countries assigned and good working knowledge of requirements across International region
Understands constitution of CTD modules; non-clinical, CMC, Clinical
Understanding of commercial goals and strategy for International region
Takes initiative for professional development & seeks opportunities to learn from others
Communicates complex ideas effectively across a culturally diverse environment & with Regulatory Authorities when tasks have been delegated
Ability to influence internal stakeholders
Effective project manager. Delivers quality projects in accordance with timelines. Prioritises tasks appropriately, coordinates the delivery of multiple projects
Must be flexible & adaptable to changing project priorities & work assignments
Displays a willingness to challenge the status quo & take calculated risks
Understands contributions of other departments & external stakeholders
Understands & utilises knowledge of local regulations & business practices when working across cultures

Regulatory Affairs Professional Development Program Resume Examples & Samples

Possess a Bachelors or Masters Degree in Life Science (i.e. Biology, Chemistry, Immunology, Medical Technology, Pharmacy, Pharmacology, Microbiology), Math, Engineering, Medical fields or other related discipline
Three to five (3-5) years work experience in Regulatory Affairs or related field
Must be eligible to work in the U.S. on a permanent basis
Regulatory Affairs related internship/co-op/work experience
Strong academic performance and extra curricular achievement
Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation, initiative, integrity and professional maturity
Qualified candidates must be interested in continuing careers in Regulatory Affairs
Ideal candidates will have no more than five years of regulatory affairs work experience to qualify for the this program

Regulatory Affairs Proofreader Resume Examples & Samples

Support team leaders and their projects
Proactively identify and address complex problems; assisting in developing solutions
Analyze work process and incorporate changes in schedule or deadlines
1 to 3 years proofreading experience preferably in an FDA-regulated environment related to pharmaceuticals
Demonstrated proficiency in working with Windows-based software programs such as Word, Excel, PowerPoint and Outlook
Detail-oriented and proficient at reviewing documentation
Excellent knowledge of grammar and command of the English language
Must be able to maintain high productivity and quality of work
Must work well under tight deadlines
High level of follow-through and accountability to others
Must be capable of making consistent, sound decisions as well as knowing when to involve senior staff members
Flexibility to handle coordination of projects

Regulatory Affairs Principal Specialist Resume Examples & Samples

Develops and implements regulatory strategies for new and modified products
Provides regulatory guidance and direction as a core team member on manufacturing and development teams, throughout the product life-cycle, and identifies/coordinates cross functional deliverables for submissions
Prepares submissions to obtain and maintain global regulatory approvals of products
Reviews and approves device labeling and advertising and promotional materials to ensure continued compliance to global regulations; leads the development of regulatory strategies for new claims, indications and therapies
Reviews and approves product and manufacturing changes for compliance with applicable regulations
Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review
Provide regulatory representation on corporate-wide projects related to product development, design controls, design assurance, sustaining engineering and regulatory business systems
Provide expertise and guidance in interpreting regulations and agency guidelines
Develop and maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements
Build Quality into all aspects of job performance by maintaining compliance to all quality requirements

Manager, Government & Regulatory Affairs Resume Examples & Samples

Promotes and advances the interests of the company at the federal, state and local levels to shape emerging issues and to enable CCI to operate in its markets without undue legislation, regulation, or taxation restrictions
Advocates with elected officials to shape public policy in favor of Cox
May develop grass-roots campaigns to advocate Cox¿s position on important issues
Coaches management on tactics for maintaining good relationships with public entities and appearances before legislators
Continually evaluates results of government relations activities, develops strategies, and adjusts activities to meet changing local conditions
May manage political donation program, PACS program, and other influencing strategies
Negotiates franchise agreements and renewals at the local and state level
Develops and implements tactical plans for department including priorities, objectives, and timelines to meet performance goals
May be a People Leader or a Functional Manager without direct reports; directly leverages, influences, and has on-going access to reporting/non-reporting resources to achieve results
Manages alignment and consistency in people practices, management activities, and customer service delivery in an effort to achieve goals
May develop policies and procedures for department to standardize practices
Establishes and leverages strong partnerships with key departments and internal/external customers
May participate in hiring decisions, employee development, training and managing performance. Motivates and coaches others to achieve department and company goals
May be responsible for budgeting

Regulatory Affairs Compliance Specialist Resume Examples & Samples

Communicate directly with customer and internal company resources to complete information needed for the complaint file
Monitor and facilitate product return for complaint investigation and analysis
Clarification of information provided during the Intake process to provide better clarity surrounding event descriptions
Review labelling and literature for regulatory concerns
Utilize risk management process to determine potential and actual risk related to complaint events
Assist in compiling responses for additional information requests from Global Regulatory Agencies
Analyze complaint information to identify similar events or failure modes
Maintain compliance to regulations
Directly correspond with regulatory agencies with supervision
Investigate related failures, design, and manufacturing history of failed devices
Ensure complaints are classified correctly and that all supporting data for investigations are adequately documented and attached to the complaint file
Identifying product-associated problems
Assist in department initiatives and projects
Facilitate communication of complaint investigation results to sales reps/customers
Provide data for product design projects and regulatory submissions
Assisting in the development and implementation of SOPs and systems to track and manage product-associated events
Approve regulatory filing decisions
Investigate department process non-conformances or potential non-conformances
Assist in the communication of product and/or component parts deficiencies to internal and external customers
Identify and analyze non-routine product issues
Ability to communicate and network with regulatory personnel to obtain relevant information
Ability to plan and conduct meetings
Supervised work with specific direction provided by senior staff
Developing working knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures pertaining to medical devices

Regulatory Affairs Resume Examples & Samples

Primarily focuses on preparing, writing, editing, and reviewing regulatory documents and responses to regulatory authorities (e.g. Notified Bodies, FDA etc). Efforts will center on Clinical Evaluation Reports (CERs) and clinical data reports/summaries in support for all of Davol’s USA and internationally registered products (particularly focused on products with technical files, design dossiers and international dossiers)
Work with New Product Development teams, RA specialists and International Business Center RA teams to create new, and update existing CERs. This will include critical review and incorporation of data from published, unpublished and historical clinical investigations globally
Periodic updating and maintenance of CERs for Davol products with post marketing surveillance and clinical data
Participates in post-market surveillance activities by leading routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups
Organizes and incorporates information, such as references, graphics, tables, and data listings for the creation of large, technical documents
Ensures documents are produced in accordance with procedures, internal and external guidelines
Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence
Independently, critically writes and edits scientifically complex documents for substantial intellectual content
Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users
Performs MAUDE data base reviews and summarizes content
Coordinates with various departments (e.g. Regulatory, Product Development, Clinical Affairs, Preclinical, R&D and Quality) to access and identify the necessary preclinical, clinical and technical information in support of CERs
Coordinate external medical writing support/needs, as applicable (ie. External contractors)
Special projects as assigned
Bachelors of Science required, with emphasis on life science
RA Medical Writer: With Bachelor’s Degree, minimum of five years experience or with Master’s Degree, minimum of four years experience in technical or medical writing, clinical research or other technical related experience in the implantable surgical medical products or related industries. Clinical or scientific research background preferred. Experience writing CERs, highly preferred
Sr. Medical Writer: With Bachelor’s Degree, minimum of 8 years experience; with Master’s Degree, minimum of 6 years experience or with PhD, minimum of 2 years experience in the implantable surgical medical products or related industries required. Clinical or scientific research background required. Experience writing CERs required
Principal Medical Writer: With Bachelor’s Degree, minimum of 10 years experience; with Master’s Degree, minimum of 8 years experience or with PhD, minimum of 3 years experience in the implantable surgical medical products or related industries required. Clinical or scientific research background required. Experience writing CERs required
Working knowledge of clinical research, device development processes, regulatory requirements, good clinical and data management practices
Excellent English language skills, especially writing and proofreading. Technical/ medical writing is required for this position; minimum of two years experience highly preferred
Knowledge in narrative and systematic literature reviews required. Creativity with interpretation and presentation of data an asset
Excellent understanding of scientific or clinical research and methods required
Understanding of statistical data and good data management practices required
Strong oral communication, presentation, project management and prioritization skills
Excellent interpersonal relationships
Must be able to handle a variety of projects at the same time
Ability to travel approximately 20% of time
Regulatory experience with medical device registrations preferred
Clinical understanding of soft tissue repair devices, and BioSurgery sealants and hemostatic products would be an asset
Determination of level will be based upon years of experience & demonstrated knowledge/skills

Manager, International Regulatory Affairs Resume Examples & Samples

Prepare, coordinate, manage or maintain simple or complex regulatory submissions (e.g., meeting packages, marketing applications, variations, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival) and other meetings as needed
Act as liaison between Regulatory Affairs and other functional areas, including global counterparts; represent Regulatory Affairs in cross-functional team meetings
Interface with external regulatory groups (e.g., vendor, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission of regulatory submissions
Identifies regulatory requirements and critical gaps for assigned projects and provides guidance to the global development team
Develop and maintain international regulatory knowledge and promptly inform team of regulation and guidance changes
Implement and manage project management initiatives as assigned for various Regulatory Affairs projects
Ensure regulatory compliance of marketed products is maintained

Regulatory Affairs Supervisor Resume Examples & Samples

Experience in regulatory affairs and quality management systems within the Medical Device Industry
Bachelors Degree (BS); Masters Degree (MS) is an advantage
Strong knowledge of medical device legislation BR, US, EU and Latin America and corresponding guidelines
Strong knowledge of quality system requirements specifcially ISO 13485 and FDA’s 21 CFR Part 820
Documented working knowledge of product development processes in medical device industry
Fluent in English, Spanish is a plus
Experience in preparation for and participation in notified body audits and FDA inspection
Experience in managing cross functional projects and teams

Manager Quality & Regulatory Affairs Czech Republic Resume Examples & Samples

Open-minded, interested in the bigger picture and thinks beyond borders
Capable to take responsibility to lead team and projects
Usage of Software Tools (Excel with analytical functions, PowerPoint, etc.)
Fluent in English and Czech
Knowledge of EN ISO 9001 or EN ISO 13485
Requires knowledge of regulatory affairs

Specialist, Regulatory Affairs Resume Examples & Samples

The Specialist, Regulatory Affairs requires a minimum of two years experience in the medical device industry
Experience with class II medical devices is a plus
A Bachelor of Science degree in a scientific or engineering discipline is required, a Master’s degree preferred
General knowledge of global and/or domestic regulatory laws and regulations, industry practices and standards
Able to apply general regulatory concepts and principles
Familiarity with international Biocompatibility requirements
Familiarity with UDI

Regulatory Affairs Product Specialist Germany Resume Examples & Samples

Bachelor’s degree or equivalent in pharmacy or related scientific discipline in life sciences. Higher degree/PhD or MBA in RA is an advantage
Minimum of 5 years experience in Regulatory Affairs or equivalent within a pharmaceutical company, CRO, or similar organization
Scientific knowledge within clinical development and registration of medicinal products (and devices)
Good technical writing skills; familiar with eCTD Modules
Good oversight and knowledge of regulatory laws, policies and guidelines within EU
Structured and organized working with excellent written and verbal communication skills
Negotiation skills at agency level
Detail oriented but keep overall regulatory picture
Proofreading and editing skills
Solution oriented with a risk based approach in mind
Ability to manage multiple projects under strict deadlines
Ability to identify compliance risks and escalate when necessary
Comply with regulations and standards and protect Shire´s public reputation

Compliance Specialist, Regulatory Affairs PCG Resume Examples & Samples

Handles multiple regulatory matter types including: inquiries, exams and state registrations
Mitigates regulatory, litigation and reputation risk to the firm as it relates to the various regulatory matter types. Works independently on complex cases requiring originality and ingenuity with some latitude for un-reviewed actions or decisions
Routinely interacts with Chief Compliance Officers, Regional Compliance Managers, Financial Advisors, Branch Operations Managers, Branch Managers, Sales Management, Legal Department, Regulators, various product and operational areas of the firm
Support management in the identification, escalation and resolution of issues presented during the course of regulatory exams and inquiries
Investment concepts, practices and procedures used in the securities
Conducting and analyzing compliance reviews and/or materials to identifying irregularities
Letter writing, verbal and written communications
Ability to use multiple electronic systems and identify appropriate subject matter experts to compile necessary responses

Regulatory Affairs Scientist Resume Examples & Samples

The contractor shall provide broad experience in medical product development and the FDA regulatory process
The contractor shall serve as a core member of IPTs and team leader of internal regulatory teams, which includes: review, editing, and coordination of document submissions to the FDA; identifying regulatory issues that need input from other regulatory SMEs and obtaining that input; aiding with clinical and nonclinical protocol development and review; providing guidance and regulatory strategy; coaching IPTs in the conduct of meetings with the FDA; and serving as a point-of-contact with FDA and regulatory staff of external collaborators
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer
Performs light duties and other related duties as required and assigned
Prior experience as an FDA regulatory scientist or experience representing a sponsor before the FDA is necessary
The contractor shall possess prior experience as an FDA regulatory scientist or experience representing a sponsor before the FDA
The contractor shall have strong written and verbal communication skills and possess demonstrated experience in medical product development and GxPs
The Contractor shall possess a minimum of a bachelor’s degree in biomedical science or equivalent experience
This position requires secret clearance

Pm-regulatory Affairs Executive Resume Examples & Samples

1) New Product Registration
Submits applications for Marketing Authorisation for new products according to local or corporate strategies
Acts as the interface between the Company and the local Regulatory Bodies
Monitors the progress of the assessment of the submission and coordinate timely responses to queries raised by the authorities
2) Product Maintenance
Implementation of the Company Core Data Sheet (CCDS) in accordance to the Corporate CCDS SOP
Carry out regulatory activities according to the Corporate Procedure
Timely product license renewal in according to the corporate procedure
Provide inputs as required following the corporate procedure. Act as the main contact for Primary Packaging Material and Artwork Management Tool
Withdrawal of marketing authorisation/portfolio management - in accordance to the corporate SOP "Withdrawal of Marketing Authorisations"
3) Maintenance of Regulatory Databases
Ensure regulatory database is kept up to date
Work closely with Regional RA and others on the clinical trial application in Malaysia to ensure correctness of documentation and information in company database
Local databases is kept current with new submissions & approvals
4) Regulatory Intelligence
Maintain awareness of local regulations relating to drug registration
Provides feedback to corporate & local management on future developments and any changes
Co-ordinates feedback to national agency/pharmaceutical industry association on new guidelines proposals
Ensures that updates or new regulatory requirements are reflected in company database or other information sources
5) Regulatory Compliance
Ensures local implementation & compliance with Corporate Policies, Processes, Procedures and Guidelines relevant to DRA activities
6) Other Responsibilities
Assigned responsibilities in the context of regulatory affairs as requested by immediate superior
Work closely with internal stakeholder for supply and/or launching planning
Complete assign online training modules in a timely manner
Clinical trial: Support the development of Clinical trial label and local application

Regulatory Affairs Senior Director Resume Examples & Samples

Advanced degree in a science related field and/or other appropriate knowledge/experience
Must have previous experience in leading Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.)
>10 years experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas - Oncology
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority
Experience in relevant therapy area (small molecules & biologics) is preferred
Proven leadership and program management experience
Ability to think strategically and critically evaluate risks to regulatory activities
Ability to work strategically within a complex, business critical and high profile development program
Successful contribution to a major regulatory approval at a global level
A scientific and clinical understanding of the regulatory sciences
Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills

Head of Regulatory Affairs Resume Examples & Samples

Responsible for directing global regulatory strategies for assigned projects and programs
Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks
Provide regulatory guidance to company personnel throughout the research and development process
Direct the organization and preparation of clear and effective submissions
Prepare and deliver effective presentations for external and internal audiences
Monitor and analyze appropriate regulatory agency activities in areas of interest to the company
Develop and maintain highly capable and dedicated regulatory staff. Guide subordinates in carrying out responsibilities. Responsible for coordinating subordinate activities and career development
Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position
Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development
Allocate representation on relevant project teams
Provide input to Regulatory Senior Management teams
Foster a global view as part of the whole regulatory team
Take steps to actively improve interdepartmental communications
Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations
Is likely to have presence on external regulatory committees/trade associations
Assess compliance of CMC documents with current Guidelines and Regulations
Recommend strategies to achieve such compliance if needed
Assess impact of proposed CMC changes to licenses or clinical trial applications
Direct global clinical and pre-clinical regulatory strategies
Direct global life cycle management of products
Actively promote relationship building between the ROW team, distributors and commercial teams
Direct the ROW filing strategy for new submissions
8 years pharmaceutical/biotechnology industry experience with technical management experience
Minimum of 6 years in Regulatory Affairs
Good knowledge of applicable regulations
Experience in interpretation of regulations, guidelines, policy statements, etc
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
Experience in European regulatory pathways for Biosimilars and previous experience in filing Biosimilars
Experience in interfacing with relevant regulatory authorities
Foster effective, positive interactions with regulatory agencies, and corporate partners
Ability to lead and influence project teams, committees, etc. to attain group goals
Demonstrate excellent leadership and communication skills
Ability to represent the department in project teams, committees and external meetings
Demonstrate strong organizational skills, including the ability to prioritize personal workload
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams
Well organized, detail oriented, effective written and oral communication skills
Supervisory experience
Ability to guide, train, supervises and prioritizes workload of direct reports
Computer literate

100

Associate Director of Regulatory Affairs Resume Examples & Samples

Review outgoing FDA correspondence (ANDAs, amendments, supplements) for completeness, correctness and compliance to FDA regulations and guidelines
Assist in the development and communication of and facilitate proper implementation of regulatory strategies to Development and Operations professional staff on product specific issues
Review and approve internal change control documentation
Review incoming FDA correspondence and collaborate in the determination of required elements for response
Direct FDA Contact (via telephone)
Interpret for the Regulatory Affairs department and other departments, as appropriate, the impact of new FDA guidelines, policies, regulations, etc. and conduct training, as needed
Responsible for creation and maintenance of training manual for RA Employees. Also responsible for the training of new RA Employees
Provide input, as needed, on technically challenging projects
Review and provide comments to Director or VP regarding documents disseminated by GPHA
Interface with R&D group regarding complex development issues and associated regulatory strategy
Follow Teva Safety, Health, and Environmental policies and procedures
Minimum BS degree in scientific or healthcare discipline or equivalent combination of education and related experience
Education Preferred
Ph. or Pharm.D. MS or Ph.D. in scientific or healthcare discipline or equivalent combination of education and related experience
Minimum 5 years in pharmaceutical regulatory affairs, with an emphasis on CMC
Minimun of 5 year management experience with a proven ability to manage a large department
Specialized or Technical Knowledge Licenses, Certifications needed
RAC certification beneficial, but not required; working knowledge of chemistry, manufacturing and controls, as needed for ANDA submissions. Prior pharmaceutical experience involving chemistry or manufacturing

101

Product Safety & Regulatory Affairs Team Leader Resume Examples & Samples

Maintain in-depth knowledge of relevant regulations and ensure transfer and retention of knowledge
Awareness of broader regulatory landscape outside of own responsibility affecting the business
Provide guidance to ensure compliance of AkzoNobel raw materials and products
Produce regulatory compliance statements for customers
Active participation in advocacy and lobbying activities such as trade associations, consortia or with authorities
Have a good understanding of customer needs and relevant regulatory topics affecting the business
Identify new regulatory developments and trends and market needs/opportunities; translate these into opportunities for own area/domain and share these with other professionals
Translate complex regulatory requirements to practical implications for the business
Identify potential non compliances and areas of risk to the business
Provide suggestions for compliance and issue management to business
Establish the impact on Performance Coatings SMUs of legislative changes and communicate legal requirements
Lead /participate in cross functional project teams as required
Lead /participate in PSRA project teams as required
Ensure validity and accuracy of data
Support Performance Coatings’ businesses Examples
Review new products, new raw materials and product changes for regulatory compliance
Conduct national inventory reviews, transportation reviews and AN procedure reviews such as for the priority substance program
Conduct risk assessments to determine if uses are safe
Advising on risk assessment strategy/refinements
Prepare and submit dossiers
Peer review of documentation
Good literacy and numeracy skills (essential)
Competence in the use of Microsoft Office (essential)
Understanding of applicable Chemical/Product Regulations (essential)
An inquisitive nature and commitment to understanding the needs of SMUs and customers (essential)
Team building /project management skills (desirable)
Experience in PSRA role or RD&I or other relevant function
Organized and a strong attention to detail
Fluent in local language
Good interpersonal skills, working well as part of a team (essential)
Ability to understand complex material and make informed decisions based on that material (essential)
Ability to produce clear and comprehensive reports and make recommendations using the available data (essential)
3 to 5 years relevant experience (desirable)
Data manipulation and analysis (desirable)
Experience of working within the framework of a quality management system (eg ISO 9001:2008) (desirable)
Experience of leading project teams (desirable)
Line management experience (desirable)
LI-SS

102

Regulatory Affairs Product Lead Turkey Resume Examples & Samples

Prepare the registration dossiers in line with the local legislations for new products and follow-up the approvals
Make variation submissions and follow-up approvals for current products
Prepare GMP inspection submissions and attend GMP inspections with the inspectors, follow-up Certification process
Ensure the receipt of MOH requests on time from the licensor company for new products and products under registration
Provide regulatory input for internal contacts for the area of responsibility
Follow-up all regulatory changes closely and take required actions on time
Efficient communication with MOH and related agencies

103

VP Regulatory Affairs & Product Integrity Resume Examples & Samples

People – Demonstrated leadership and development of people and teams, particularly in a culturally diverse environment
Technical – Brings strong technical (particularly regulatory, toxicological, clinical, microbiology) knowledge and ability to anticipate and solve problems
Execute with excellence – Ensures timely planning and execution within regulatory, human safety, microbiology, and clinical teams to meet project timelines
Communication – Excellent and compelling communication up and down the organization; able to simplify complex data and situations for non-technical audiences
Collaboration – Has a strong network of collaborators both inside and outside the Company to help manage complex regulatory issues. Abilities and competencies strongly recognized external to the Company in order to build and maintain the Company’s reputation in the regulatory arena
Actively builds strong, influential relationships up / down and across a culturally diverse organization, particularly with diverse parties and corporate functions, to ensure strategies and aligned and actioned, best practices are shared / followed; strong negotiation skills

104

Senior Specialist, Regulatory Affairs Resume Examples & Samples

A minimum of five years of experience within medical device regulatory affairs is required, for the Sr Regulatory Affairs role
A Bachelor’s degree is required. A science degree is strongly preferred
Experience with Class II devices preferred. Relevant experience includes, experience with hemodynamic monitoring devices
Experience in preparing US and EU product submissions are required
Must be competent in applying the appropriate l regulatory requirements for new products or product changes as it relates to labeling and advertising of class II and III devices. –
Requires familiarity with new product development systems
Must possess a strong working knowledge of US /EU regulations that affect Class II and/or Class III devices
Must have strong written and verbal communication skills, and have experience working on cross functional project
Strong ability to problem solve and apply analytical thinking is required

105

R&D Regulatory Affairs Systems & Documentation Coordinator Resume Examples & Samples

BS in Nutrition Science, Food Science, Engineering, Technology or equivalent as minimum
Strong collaboration, communication and project management skills
1-2 years' experience in regulatory affairs, quality, technology or systems management preferred

106

Regulatory Affairs Proposal Developer Resume Examples & Samples

Review Requests for Proposal (RFP). Identify information for proposal text and budget development; and work closely with proposal development team to prepare and finalize proposals
Team Lead on assigned projects, to develop proposals and budgets
Perform quality control edits on all documents and oversee the finalization of documents and distribution to the customer and internal departments
Update and maintain corporate databases as required and ensure accurate information is included in tracking reports
May participate in customer meetings

107

Senior Scientist, Regulatory Affairs Resume Examples & Samples

To provide regulatory guidance to Product Development and Marketing in support of the EU Chocolate business
Coordinate, develop and approve product declarations including nutrition labelling and claims for the UK & European market
Review raw material and product specifications
Review product designs and artworks for Regulatory compliance
Provide guidance on any advertising material printed/ online or TV
Interact and communicate as a regulatory partner with multiple functions, work in close cooperation with product/packaging development, marketing, legal, supply chain, quality, corporate affairs, country management and product change partners in our business units and plants
Support Consumer relations teams with queries regarding our products
Provide support and guidance to the business in the implementation of new legislation. Assess the impact of emerging legislation to ensure that all products meet the regulatory requirements
Lead working groups or advise team members and within the cross category Regulatory team on Meridian system support
Train and support less experienced team members
Assist manager with risk assessments with regard to deviations requests
Input in to the monthly tracking list
Attend and input to EU productivity meetings
Bachelor/Master or equivalent in Food Chemistry, Food Technology, Food Science or Nutrition or Law degree if supported by food industry experience
Used to working to deadlines
Experience with relevant systems (e.g. Meridian)

108

Nordics Regulatory Affairs Product Lead Resume Examples & Samples

Provide regulatory advice to support the Nordic LOC strategy for assigned product franchis(es)
Ensure in conjunction with the Nordic-Baltic Regulatory Lead and country RA Leads that regulatory requirements of the Nordic region are fully represented in discussions at Global, Regional and Local levels
Support and align with other departments/functions on needs re periodical requests (e.g. tender support and P&R submissions)
Provide local support to the EU Regulatory strategists for local submission when necessary in case of specific contact to take with the agency or review of national requirements
With support of QA/Compliance may participate in drawing up and monitoring Company standard operating procedures, as well as checking on their application, in cooperation with superiors

109

Regulatory Affairs Office, Associate Resume Examples & Samples

Support Reporting and Analytics Manager with data entry & reporting of regulatory issues
Manage communication process for regulatory reports and letters
Support database administrator with RAO tools Administrative and coordination support for regulatory exams that include UARs, meeting room and scheduling
Ensure RAO equipment/computers maintenance
BA/BS Degree or comparable work experience
At least 5-7 years’ experience in diverse business roles and regulatory relations

110

Regulatory Affairs CMC Manager Resume Examples & Samples

Contribute to the development of stage-specific CMC regulatory content, including marketing applications for US, Europe and selected global markets, with an eye towards sound product lifecycle principles
Provide CMC regulatory guidance regarding submissions and CMC changes such as analytical changes, specification changes and manufacturing changes
Charter and manage submission teams through all stages of submission execution, leading to delivery of high-quality, on-time CMC Regulatory submissions. Ensure adequacy of required CMC documentation for regulatory submissions (IND, CTA, NDA and MAA) for U.S. and international applications
Contribute to effective planning and CMC Writing Team resource allocation to support a range of programs and supporting submissions
Participate in meetings with other functional groups on CMC regulatory issues
Maintain awareness of and expertise in FDA and ICH guidelines related to CMC regulatory topics
Contribute to development and implementation of new and improved processes
Interpret harmonized and regional regulatory CMC guidelines in order to drive the refinement of quality systems, where they have regulatory and/or submission elements
Prepare CMC responses to questions from regulatory agencies with guidance
Demonstrate proficiency in the utilization of document publishing systems to ensure high quality CMC filings to FDA
Provide RA review of change control assessments
Provide manufacturing site RA support as appropriate
Provide RA review of deviation assessment and investigational support
Provide RA review of document change(s)
Provide RA review of batch records for updates and changes
Provide RA support for internal and external site inspection as needed
Provide interpretation and communication of CMC Regulatory Intelligence as appropriate with guidance
Provide interpretive analyses regarding impact of complex regulatory information with guidance
Participate and take an active role in all GMP and departmental training to ensure compliance with GMPs and guidelines
Keep abreast of regulatory knowledge and initiatives including ICH, USP, EP, FDA and other Health Authorities as well as other regulatory intelligence sources
Under some guidance, formulate strategies to maintain submission goals
Foster a collaborative environment and contribute to a positive, dynamic, high-energy organization

111

Regulatory Affairs Operations Specialist Resume Examples & Samples

Managing the FDA establishment registrations and device listings process for all Philips facilities. Providing input to management regarding Philips-wide establishment registration strategy
Managing the medical device manufacturer/distributor US state licensing process for Philips facilities
Owning the FDA Certificates to Foreign Government and embassy authentication submission strategy and execution for all Philips businesses
Owning and maintaining the regulatory deliverables database across all Philips businesses, creating a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals
Owning and maintaining department procedures related to the above responsibilities
Notarizing regulatory documents

112

Regulatory Affairs & Quality Assurance Specialist Resume Examples & Samples

Preferably university degree in a relevant scientific discipline (pharmacist is preferable) – however, candidate with the right profile from a “Hoge School” in Pharma or Healthcare may qaulify as well
Minimum of 3 years pharmaceutical industry experience in the relevant areas of regulatory and quality assurance
Specific expert knowledge in the area of regulatory affairs and preferably quality assurance
Must understand the principles of quality management and will be conversant with e.g. ICH Quality Guidelines Q9 and Q10, and EU Guidelines 2013/C 343/01 on Good Distribution Practice
Ability to build national networks and relationships
Proven influencing skills with trade associations & regulatory bodies
Anticipate trends/changes in regulatory environment
Advanced understanding of structure & workings of regulatory bodies in country assigned
Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail
Inter-dependent partnering skills, team-oriented and ability to influence outcomes
Excellent communication skills (verbal and written) in Dutch as primary language. Very good in English
Domestic and International travel may be necessary

113

Regulatory Affairs Operations Specialist Resume Examples & Samples

Provide technical leadership for Corporate process improvement and systems initiatives
Provide strategic leadership to improve overall department processes and efficiencies
Participate in due diligence activities, assess, and lead file transfer activities for acquisitions
May mentor and train junior level staff
Bachelor’s Degree required, in a scientific or other related discipline
RA Operations Specialist: Minimum 2 years’ experience with regulatory publishing requirements for medical devices, clinical or other related experience
Senior RA Operations Specialist: Minimum 4 years’ experience with regulatory publishing requirements for medical devices, clinical or other related experience
Specialized technical skills: Data entry and document creation. Experience with electronic submissions (FDA eCopy, eCTD, etc) preferred. Full ability to use PC based software programs (i.e. Microsoft Word, Excel, Powerpoint, Access, and Adobe Acrobat) required. Ability to successfully use Corporate-wide software programs such as Sharepoint, Box.com, MasterControl, TrackWise, and others, as applicable
Strong personal leadership and self-direction. The individual must be able to self-manage parallel priorities and complete daily workflow based on general instructions
Demonstrated ability to work with, coordinate, and prioritize demands from multiple stakeholders
Ability to travel approximately 10% of time
Determination of level will be based upon years of experience & demonstrated knowledge/skills

114

Project Leader, Regulatory Affairs Resume Examples & Samples

A minimum of a Bachelor’s Degree is required
A minimum 4 years of working experience within the Over-the-Counter (OTC)/ prescription Pharmaceutical, or Medical Device Regulatory environment or 0-3 years with a PharmD or PhD is required
General knowledge, understanding and application of principles, concepts and practices of FDA regulations required
Regulatory knowledge to maintain legal status of products and minimize risk requirement is required
Knowledge of regulatory requirements (FDA & FTC) and general advertising standards associated with promotion of medical devices required
Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, marketing, etc.) is required

115

Principal Specialist, Regulatory Affairs Resume Examples & Samples

1) Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals of Companion Diagnostic products in global markets
2) With Regulatory Sr. Management, develops regulatory strategies related to CDx product development
3) Provides regulatory assessments and plans for international product registrations and approvals
4)Interacts and collaborates with pharmaceutical partners in joint meetings
5)Ensures the accurate and timely preparation of regulatory submissions and reporting in accordance with Company goals, regulatory requirements and partnership contracts
6)Works across the Agilent organization to ensure alignment of regulatory processes, standards and compliance. Provide expertise and advice in obtaining CDx product registrations and approvals in the Pacific Asian market
7) Represents the Company in 3rd party meetings, especially the FDA, and regulatory associations
8) Stays abreast of global IVD regulations and guidances, especially those relevant to Companion Diagnostics
5 + years relevant regulatory experience

116

Regulatory Affairs Executive Resume Examples & Samples

Prepare the registration dossier to comply with local regulation
Check and request additional document to Head Quarter
Submit the registration dossier and follow up with realted officers, experts to get the results in timely manner for assigned products
Coordinate with medical team to update PI for assigned products
Coordinate with person in charge of local content to get approval of drug label for assigned products and do checking labelling compliance
Coordinate with Supply Chain Manager to declare the registration price for assigned products
Prepare and apply the application and necessary formalities to get the registration samples for assigned products

117

Regulatory Affairs Operations Specialist Resume Examples & Samples

3 + years of regulatory affairs related experience
Working knowledge or experience in regulatory submission work
Advanced knowledge of spreadsheet/graphing, including knowledge of Microsoft Office applications, including Word, Excel, PowerPoint
510(k), IDE or PMA experience

118

Regulatory Affairs Remediation Project Manager Resume Examples & Samples

BA/BS in science or technical field
3+ years demonstrated Project Management experience
5+ years Medical Device Regulatory experience with pharmaceutical and/or medical device manufacturers. EU experience desirable
2+ years of experience successfully managing projects per aggressive timelines, thrive under pressure
Ability to manage critical decision-making through consensus
2+ years of experience in successful coordination and collaboration with cross-functional departments (e.g. R&D, DQE, Quality, Manufacturing, Clinical Affairs, etc.)
Effective negotiation and team building skills
Excellent interpersonal and influence management skills
Strong written, verbal and presentation skills
Proficiency in MS Excel and MS PowerPoint

119

Senior Director of Quality Assurance & Regulatory Affairs Resume Examples & Samples

Develop and implement China CFDA Registration (including Clinical Affairs) and CFDA compliance strategies for new and current products, taking into account current and proposed changes in CFDA regulations, clinical partners, CFDA audit practices, technical methods and standards
Ensure post-market product CFDA compliance, demonstrated by timely, consistent review of recall notification within statutory guidelines, minimizing the risk of CFDA actions that could impact our business
Establish and maintain close relationships with appropriate China regulatory agencies for effective registration requirements and post-market activities
Maintain strong working relationship with China Commercial organizations to ensure alignment of regulatory strategies to business priorities
Develop company capability to manage closed-loop quality processes in China. This includes development of processes and talent
Communicate with regulatory agencies to determine status and facilitate approvals of products registrations
Remain abreast of changes in relevant regulations including product testing, clinical trial, product registration and post-marketing action both proposed and implemented. Effectively communicate this information to the appropriate functional groups
Provide guidance for the effective clinical studies and facilitate the product registrations within the budget and expected timeline
Supply regulatory impact of proposed changes to current manufacturing processes and marketing strategies
Maintain expert knowledge in product specific China regulatory requirements and be a point of contact/consult for registration strategies
Maintain strong working relationship and communications with Business Group regulatory leaders
Construct a strategic vision for development of the organization and the people. Passionately develop skill and capability
Represent Company in various agency and industrial conferences in China
Build and develop a high performing regulatory affairs team
Prevent business interruptions due to compliance issues
Fifteen years of relevant experience in a regulated medical device/diagnostic industry
Ten years of supervisory and management experience
Subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics
Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and in vitro diagnostics
Experience in registration and commercialization of medical device and diagnostic products
Ability to develop effective regulatory strategies and apply regulations to pre-market and post-market strategies
Possess a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Product Development
An established personal relationship with the CFDA and other regulatory agencies
Proven leadership and managerial skills in order to build and sustain a vision for the work group
Demonstrated track record of developing organizational capability
Collaborative leader, building consensus while championing global regulatory initiatives
Solution focused and always with decisions and actions grounded in data and facts
Ability to adapt to complex landscape of stakeholders, and still collaborate effectively
Advanced educational degree in medical science, core science, or engineering
15 Years of work in CFDA Registration and Clinical Trials for Medical Devices
Strong participation in CFDA compliance, including GXP, audits, and inspection management
Work in a medical device or comparable environment with working knowledge of sound methods for control of documents and records
Experience to both large-company work culture and small-company work culture
Familiarity with a wide variety of PLM practices and procedures

120

Regulatory Affairs Leader Resume Examples & Samples

File / Maintain regulatory deliverables
Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies
Support local regulatory authority / notified body inspections as required
Educate, train, & advise company professionals to ensure compliance with regulatory requirements
Coach and mentor other RA professionals
Bachelor’s Degree (or internationally recognized equivalent) & minimum of 3 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience in medical device or pharmaceutical industry or with medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration, adverse event reporting, & recalls
Proven application of analytical skills in a regulatory environment
Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English
Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research
Strong problem solving and negotiation skills
Must be willing to travel up to 10% of time
Advanced Degree in scientific, technology or legal disciplines
Demonstrated experience interfacing with regulatory agencies( e.g KPPB, TFDA, FMHACA, RPB, FDA,MHLW, Health Canada, KFDA etc) and standards bodies such as AAMI, IEC, ISO, UL
Knowledge of Quality Management Systems (QMS)
Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast pace environment
Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situation and their impact on GE Healthcare regulatory strategies; and
Experience with adverse event reporting and recalls

121

Quality Assurance & Regulatory Affairs Leadership Program Resume Examples & Samples

All goals specific to rotational requirements
Master’s degree in engineering, science, biology, clinical research, health policy, health product regulation, public health, quality assurance or related field; Minimum cumulative GPA 3.0/4.0
Geographic flexibility
Strong analytical, problem solving and communication skills
Ability to effectively communicate in English (or local language)
Commitment to and passion for quality compliance, product quality and patient safety
Previous medical-industry work experience

122

Ireland Regulatory Affairs Product Specialist Resume Examples & Samples

50%
Provide regulatory advice to support the UK & Ireland Business strategy
Ensure in conjunction with UK/Ireland Regulatory Lead that regulatory requirements of UK & Ireland are fully represented in discussions at Global, Regional and Local levels
May support EU strategy on specific projects on development/marketed products
Support and align with other departments/functions on needs re periodical requests. (e.g., tender support and HTA submissions)
Provide local support to the EU Regulatory strategists for local submission when necessary in case of specific contact to take with the agency or review of national requirements
With support of QA/Compliance may participate in drawing up and monitoring Company standard operating procedures, as well as checking on their application, in cooperation with superiors
Sign off of IMP artwork in accordance with applicable European guidelines
Submission of PASS protocols to the national regulatory authorities
May be involved in clinical trial submissions for interventional company sponsored clinical trials
Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business
Creates an open collaborative environment of continuous improvement within LOC stakeholders and Global functions
Demonstrated ability to assess the internal and external environment to recommend appropriate risk-taking
Incumbents at this level are involved in a variety of diverse scope and complexity of projects which require strategic thinking and thorough and practical solutions
Ability to handle multiple tasks and work under pressure

123

Regulatory Affairs International Strategist Resume Examples & Samples

This position is responsible for the implementation of regulatory strategies through coordination and preparation of submission documents for the registration of new products and changes to existing products in international markets (i.e. Asia Pacific, Latin America, Middle East, Africa and Europe) in partnership with other International Specialists
Maintain interactions with departments that are outside of Regulatory Affairs (Local Country and Business Unit RA, Marketing, Legal, Medical/Clinical Affairs, Product Development, Supply Chain, etc.) to help manage complex negotiations with global regulatory authorities (as needed) through the local RA representatives
Collect, organize, maintain and archive regulatory authority market clearance and product registration documentation
Act as a liaison with third-party distributors and/or Regulatory personnel within the Bayer affiliate locations to address questions and issues that arise as part of the registration process
Work cross functionally with various businesses in Medical Care
Support Bayer Radiology worldwide product registrations by preparing and coordinating regulatory submissions
Ensures timely registration of products in compliance with applicable regulations and guidance
Maintain up-to-date knowledge of global regulations
Maintain country specific site registration requirements
Contribute to the maintenance of the current regulatory databases to ensure accurate regulatory data
Liaise with RA leads for new product development or line extensions
Provide Regulatory guidance on the impact of post-market product changes and device modifications
Provide Regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations
Collaborate with Bayer Radiology Regional regulatory representatives to understand local regulations
Bachelor's degree from a four-year college or university required
Minimum of 5-9 years of experience in the healthcare industry including Regulatory Affairs
Previous experience with global Regulatory filings
Project team environment experience
Proven track record in people/team building skills
Detail-oriented and well-organized
Must be motivated to work independently as well as with crossfunctional teams
Solid communication skills in English and ability to communicate in regional language is also desired
Skill and determination to reach successful outcomes in negotiations with both inside team clients and outside parties e.g., Regulatory agencies
Self-starter with a proactive and energetic attitude

124

Regulatory Affairs Established Products Resume Examples & Samples

Strategic regulatory input in Post-approval and Life cycle management including Portfolio optimization and Issue management
Liaising and negotiating with Regulatory Agencies, external partners and Local Operating Companies
Advise teams on required documents and processes to support Regulatory Agency contacts, submission and maintenance activities
Understand the competitive landscape, e.g., views of HA, regulatory precedents, labelling differences and therapeutic area issues
Ensure compliance and alignment with regulatory requirements and company processes
University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
Regulatory experience in drug development and commercialization. As this function is responsible for a broad portfolio of established products additional experience with late life cycle management & issue management will be an advantage
Experience with EU regulatory procedures (CP, DCP/MRP, referrals & national)
Experience in working in project teams and/or a matrix organization
Excellent oral and written communication skills
The ability to work successfully within a collaborative team environment and as an individual contributor and decision maker within a cross-functional remote organization

125

Associate Director, CMC Regulatory Affairs Resume Examples & Samples

Responsible for developing global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans
Lead the CMC regulatory activities for designated programs for small molecules products (API and drug product)
Support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidances
Additional responsibilities may include: contribute to the preparation and editing of clinical trial and marketing applications; correspondence and direct interaction with global Health Authorities; development of product-specific regulatory strategy documents; technical review and approval of master protocols, reports and other source documents; external influencing and commenting on guidance and new regulations
Ensures the development strategy meets global regulatory requirements over the lifecycle of the product
Ensures that the CMC regulatory strategy is in alignment with the global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile (TPP)
Ensures communication and alignment of the CMC regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader), project Compound Development Teams, Supply Chain, and all other internal and external stakeholders, and appropriately escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product
A Bachelor’s degree in Pharmacy, Chemistry, Biology or a related science/technical field with a minimum of 10 years of relevant industry experience OR a Master’s degree with a minimum of 8 years of relevant industry experience OR a PhD with a minimum of 5 years of relevant industry experience is required
A minimum of 3 years of experience in Regulatory Affairs-CMC is required
Strong knowledge of EU, FDA and global regulations is required
Experience in leading Health Authority meetings (FDA, EMA, Health Canada and others) is highly preferred
Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required
Proficiency with the MS Office suite of products and data management tools is required
Strong interpersonal, communication, teamwork, leadership, conflict management and negotiation skills is required
This position will be based in Spring House, PA, Titusville, NJ, Raritan, NJ or Toronto, Canada and requires up to 5% travel, both international and domestic

126

Regulatory Affairs Consultant Resume Examples & Samples

Analyze and review new regulations to determine impact to the business
Manage various areas of Client Communications and Reporting
Summarize findings, field questions about regulations, and track implementation by business
Manage complaints (from members, clients and Regulators)
Track and analyze new regulatory requirements pertaining to federal regulations
Prepare summaries of analysis that include, as appropriate, relevant legislative history, comparisons to existing or proposed legislation in other jurisdictions and detailed descriptions of the operational requirements and affected departments
5+ years of experience in a healthcare regulatory environment
Experience with Medicaid
Experience in communications and / or a client - facing role
SharePoint experience
Managed care, pharmacy benefits management and / or compliance expertise

127

Regulatory Affairs Submissions Planner Lead Resume Examples & Samples

Responsible for planning, coordinating, compiling and reviewing regulatory submissions to European countries (EU and non EU) with release to Country Operations teams and/or submission to Health Authorities
Responsible for accessing and maintaining the regulatory systems and databases to fulfill daily functions
Act as the key RAO-EMEA representative in cross-functional project teams and address the regulatory submission needs; manage interactions with colleagues outside the department and make/contribute to routine decisions supporting marketing applications
Lead Submission Planning Management Teams (SPMT) meetings
Work closely with the corresponding Planner based in the HQ(US) on assigned products/projects
Work closely with Global Submission Assembly and Delivery colleagues to ensure timely assembly, publishing and archival of assigned products/submissions as per described Project Team Timelines
Assist in identifying opportunities to continually improve the efficiency of the submission process
Maintain knowledge on the European procedures (on internal and external guidelines and standards)
3 to 5 years’ experience in the pharmaceutical regulatory affairs area
Excellent written and oral communication/interpersonal skills required
Able to multitask with proven project management capabilities including managing dynamic timelines, interacting and negotiating with others, collaboration skill and excellent follow-up ability
Thorough knowledge of regulatory guidelines and procedures within the European Region
Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers

128

Regulatory Affairs Resume Examples & Samples

Under supervision of the Country Lead/ Director Regulatory Affairs, the incumbent is responsible for providing regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations, preparing submissions and renewals and maintenance of local files as well as minor translations and artwork management
Under supervision of Country Lead/ Director Regulatory Affairs the incumbent contributes in other regulatory tasks, as required
By discretion of Regulatory Affairs Management and due to organization and work load, all listed activities need not to be performed
A maximum of 2 years experience in a Registration Department or equivalent, which should include dealing directly with regulatory agencies
The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products with a specification for vaccines
Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills
The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work
A mature and disciplined approach to work is essential as is the ability to coordinate the work of others
The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties

129

Regional Liaison Regulatory Affairs Latam Resume Examples & Samples

Serves as single POC for Medical Devices and Companion Diagnostic products and assists the Director – RL Oncology
Contributes to development and execution of regional regulatory policy issues
For Medical Devices and Companion Diagnostic products creates and maintains a database of country requirements for health authority registration/approval
Supports RL-Oncology to provides regionally focused strategic input to oncology product development across region and across portfolio
Contributes to region specific aspects of a development strategy
Leads identification of regional specific elements of submissions
Monitors and communicates key strategic issues related to program progress and issues to/from countries and HQ
Helps ensure HA deficiency letters are appropriately addressed in a timely manner, by providing specific input from the regional perspective
Triages questions and responds to those asking about location of certain information in the Dossier and forward those to HQ which require subject matter expertise
Ensures alignment of strategy and priorities for portfolio of products with stakeholders such as business and manufacturing
Outstanding, interpersonal, written and oral communication skills; outstanding collaborative skills with an ability to work both proactively and reactively in a timely manner in a dynamic fast-paced environment with a “getting things done” spirit
Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities; able to manage complex problems/projects by exercising independent decision making and analytical thinking skills; knowledge/experience of regulations, registration guidelines and regulatory processes for NCEs and product life cycle maintenance in general and preferably in the intended region; ability to work independently to achieve results; ability to work in cross-functional and international environment; detail- and goal-oriented, quality conscientious, and customer-focused; ability to adhere to strict project timelines; strong team player; good judgment and problem solving skills, with ability to identify, analyze, and resolve problems in a timely manner
Good interpersonal relationships, capable to build personal interactions by trusting and driving accountability
Knowledge of Latin America regulations for innovative pharmaceutical drugs: vaccines, biotechnology and oncology
Handle of a constant job under pressure, dealing a high level of volatility, uncertainty changing and ambiguous environment
Analysis and taking of rapid decisions in crisis situations
Autonomous level for Planning & Budgeting

130

Regulatory Affairs Administrator Resume Examples & Samples

Conduct administrative activities to support regulatory department with daily routine
Purchase materials & services, confirm deliveries and maintain invoices
Support procurement of Legal Documents for regulated countries worldwide
Follow up with respective counterparts like Competent Authorities, embassies or notary offices
Maintain the Filing Systems for registration dossiers, legal documents and certificates
Support Batch Verification activities and associated maintenance of release documents (hardcopies, PULSE database)
Assist with regulatory export control and stickering as necessary
Serve as permanent backup with any other administrative tasks in absence of adminstrative assistant

131

Team Lead Regulatory Affairs Resume Examples & Samples

Coordinates and triages all submission work activity
Provides input into client processes and software to Engagement Manager for communication back to client
Main point of contact for client LRAs. Communicates issues and concerns to Delivery Lead proactively
Main point of contact for client LRAs
Regulatory Affairs knowledge
Different submission procedures (EU & US)
Good Clinical Practice (GCP)
21 CFR part 11
Excellent verbal & written communication
Ability to direct regulatory strategy and contribute to its outcome when necessary
Diploma/ Bachelor degree in Pharmacy, Life-Science
Minimum of 5 - 7 years in Regulatory Operations and Document Publishing

132

Regulatory Affairs Senior Manager Resume Examples & Samples

Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered
Oversee and review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
Authoring and coordinating responses to questions across assigned products and countries
CMC RA subject matter expertise for a group of countries within the Intercontinental region
Point of Contact with local country regulatory staff
Project management of submissions and monitoring status of applications
Responsibility for supervision of assigned team members
Active membership and participation in governance committees discussing product strategies and risk mitigation

133

Manager of Regulatory Affairs Operations Resume Examples & Samples

Establish and manage the standardization of submission formats and preparation of electronic regulatory submissions
Provide leadership for procedures on compiling and electronic publishing submissions including BLA, NDA, INDs and to FDA OPDP
Collaborate closely with US Retail RA Operation and global RA Biopharm to ensure on time and high quality submission to FDA
Manage archiving procedures of regulatory and quality assurance documents, including the maintenance of all archival systems
Lead and expert on electronic submissions maintaining up-to-date knowledge of US and ICH requirements and act as liaison to other departments on general issues related to electronic submissions
Function as US BRA lead in the implementation of an new electronic document management system
Evaluate operational processes and activities for areas of quality improvement and greater efficiencies
Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement
Responsible for regulatory intelligence including identifying new regulations and guidance, summarizing and disseminating
8 years biopharmaceutical industry experience across business platforms is preferred
5+ years regulatory affairs operation and quality assurance/compliance experience
Working knowledge of FDA regulations, industry standards, and CTD/eCTD requirements, documents formats/ standards, pertaining to regulatory operations is essential
Working knowledge of documentum system, eCTD compiling, e-publishing TOC and trouble-shooting
Broad understanding of current GXP requirements
Working knowledge with biologics preferred
Ability to work independently and focus on multiple issues and deadlines simultaneously
Experience working within a global team framework and a multi-cultural environment
Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills

134

Benelux Regulatory Affairs Product Specialist Resume Examples & Samples

Interface from LOC to EU/Global RA
Conformance to Belgian/Lux Drug Law,
Maintaining labelling information to internal and external partners,
Communicating with regulatory authority and institutions,
Supporting internal EU/Global RA function
Supporting R&D departments
Providing collaborative support for commercial teams, in particular in the frame of the new products launches in Belgium and Luxembourg
Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
Prepare, review, and approve labeling; ensure local implementation of RA SOPs
Respond to regulatory authorities questions with strict deadlines
Maintain regulatory files in a format consistent with requirements
Develop, initiate and execute regulatory submission and project plans
Manage regulatory activities relating to specific portfolio of products/projects (product owner)
Maintain and update existing regulatory marketing authorizations (MAs)
Lead or represent Regulatory Affairs in cross-functional project teams
Liaise with marketing and commercial and external partners to ensure that all local product information used are up to date
Training needs/education of medical, QA, commercial/sales team on updates and new regulations
Review promotional and non-promotional material for compliance with local regulations/Shire guidelines
Provide advice to International Commercial, regarding how to maintain compliance of Shire activities and materials with local regulations/requirements codes at International symposia/conferences to be held in their region
Manage requests for certificates like e.g. CPPs, GMPs and Copies of Manufacturing Authorizations (MA) in close collaboration with the requesting Shire subsidiary and the Belgian Health authorities. Manages the settings of “RA Benelux Export Certificates” within SharePoint
Demonstrated ability to function as the lead interface between Shire and Regulatory Authority during critical negotiations
Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies
Ability to manage multiple projects and deadlines
Strong technical system skills (e.g. word processing, spreadsheets, databases, online research)
Effectively embraces change and is able to flourish in a global structure, aligning people and processes to deliver excellence
Creates an open collaborative environment of continuous improvement within LOC stakeholders and EU/Global functions

135

UK / Ireland Regulatory Affairs Product Lead Resume Examples & Samples

Provide regulatory advice to support the UK & Ireland business strategy. Ensure in conjunction with UK/Ireland Regulatory Lead that regulatory requirements of UK & Ireland are fully represented in discussions at Global, Regional and Local levels
May support EU strategy on specific projects on development/marketed products. Support and align with other departments/functions on needs re periodical requests. (e.g., tender support and HTA submissions). Provide local support to the EU Regulatory strategists for local submission when necessary in case of specific contact to take with the agency or review of national requirements. With support of QA/Compliance may participate in drawing up and monitoring Company standard operating procedures, as well as checking on their application, in cooperation with superiors
Sign off of IMP artwork in accordance with applicable European guidelines
Submission of PASS protocols to the national regulatory authorities
May be involved in clinical trial submissions for interventional company sponsored clinical trials
Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies
Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business
Effectively embraces change and is able to flourish in a global structure, aligning people and processes to deliver excellence
Creates an open collaborative environment of continuous improvement within LOC stakeholders and Global functions
Demonstrated ability to assess the internal and external environment to recommend appropriate risk-taking
Incumbents at this level are involved in a variety of diverse scope and complexity of projects which require strategic thinking and thorough and practical solutions
Ability to handle multiple tasks and work under pressure

136

Senior Manager Government & Regulatory Affairs Resume Examples & Samples

Record of achievement in a policy or political environment
Tertiary qualification with expertise in policy or law affecting banking, business and financial services
First class writing and communications skills, including the ability to understand and simplify complex matters involving different areas
Demonstrable relationship management skills
Capability to work under pressure and to meet tight deadlines
Results focus, leadership and ability to work in a team environment

137

Specialist Principal, Regulatory Affairs Resume Examples & Samples

Develops sound global regulatory strategies for new and modified medical devices
Creates, reviews and approves engineering changes
Provides Regulatory leadership to development teams
Minimum 6 years regulatory experience; 8 years preferred
Experience working in a broader enterprise/cross-division business unit model preferred
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Experience acting as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team
Experience acting as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail
Experience supporting audits by regulatory agencies, including GMP, ISO13485, and FQA audits
Experience creating intradepartmental procedures
Strong organizational and follow-up skills, as well as attention to detail
Ability to work independently with no oversight
Master’s degree in biomedical engineering, regulatory science or a related field
Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current and up-to-date, including but not limited to US, EU, Canada, and Australia

138

Regulatory Affairs Executive Resume Examples & Samples

Minimum - a Bachelor’s degree in Political Science or related social sciences
Minimum 3 - 5 years’ experience in Corporate Affairs, Public Relations or Legal environment or other relevant experience in a multinational company
Experience in working with government and regulatory agencies. Experience in the consumer goods industry preferable
Excellent command of English (both written and spoken)

139

Regulatory Affairs Labeling Strategy Lead Resume Examples & Samples

Bachelor's degree in a scientific discipline or closely related field is preferred
5 -8 years of regulatory or related experience in the pharmaceutical/ biotechnology industry. 2-4 years of direct experience desired
Expertise in developing company core data sheet
Understanding of EU and US labeling requirements and guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and conversations
Good verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills
Good analytical, technical and problem-solving skills
Tact, diplomacy, and a flexible and positive approach
Ability to manage projects and timelines in a matrix team environment
Strong attention to detail and accuracy is a must
Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration; demonstrated ability to facilitate a beneficial resolution of conflict
Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to work in diverse teams to optimize decision-making
Ability to understand and interpret Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines
Applicable knowledge of the drug development process
Proficient in business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook
Good interpersonal and organizational skills
Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

140

Regulatory Affairs Resume Examples & Samples

Support Quality Representative for Germany, Austria and Switzerland – responsibility for compliance with quality related standards including the evolution of quality standards of the newly established direct-to-consumer business and direct-to-patient distribution
Ensures organization meets existing and future internal and external compliance standards
Maintenance of the quality system to meet the requirements of ISO 9001 and ISO 13485
Representation of ADC at industry association
Ensures product communication & promotion material meets regulatory requirements
Establishment and implementation of divisional and local quality procedures according to internal and external regulatory standards
Ensure that ADC meets local compliance standards of Environmental, Health & Safety (EHS), Affiliate Compliance Committee (ACC) requirements and other legal requirements. Drives critical improvements in compliance management analyzing changes in local regulatory framework
Acts as training coordinator for ADC Germany, Austria and Switzerland
Conducts quality, regulatory & compliance trainings
Conducts internal and external audits at affiliate sites and suppliers in Germany, Austria and Switzerland as necessary
Support of potential reportable events, medical events and field actions in close relation to customer service and vigilance groups
Management of customer requests regarding quality or regulatory related issues
Regulatory review and approval of promotional material
Reports to the Manager Regulatory Affairs, Quality & Compliance
General university-entrance diploma, preferred University Degree in Natural, Science, Medicine or Engineering
Knowledge of regulatory requirements (e.g. MPG, IVD guideline), internal & external compliance regulations and quality standards
Preferred experience: Regulatory, compliance and quality affairs of diagnostic, pharmaceutical or medical device industry
Standard Microsoft software systems
Organizational skills and high level of quality awareness
Project Management skills
Effective and motivating interpersonal communication skills
Fluent in German and English

141

Graduate Student Summer Internship Law & Regulatory Affairs Resume Examples & Samples

Analyzing state laws and regulations to provide guidance on business questions or strategic initiatives
Working on interpretation and implementation of federal and state laws in cutting edge areas including health care reform, privacy, social media, FDA and international
Working on a range of Intellectual Property issues, including trademark, patent and licensing, including the development of business guidelines and tools
Participating on enterprise projects seeking improve Aetna’s processes in critical areas including form and license filings, review and draft forms and other documents
Participating in a variety of transactional matters (including mergers, acquisitions and strategic transactions), advising on public disclosures and assisting with corporate and subsidiary management matters
Collaborating on a group project focused on delivering counsel to a diverse range of legal and business audiences
Excellence written communication skills
General business acumen

142

Associate Manager of Food Safety & Regulatory Affairs Resume Examples & Samples

Lead engagement with regulators at regional, state and local level to advance Yum!’s food safety position through trust building and education
Define and influence regulations and provide internal expertise to US brands for incidents/crises management involving ingredients, products, restaurant and restaurant operation
Establish and deepen credible and productive relationship with colleagues across functions and BUs/brands globally with a proven collaborative, leadership, and influencing style to provide regulatory update, input and guidance that minimizes regulatory barriers
Devise and deploy restaurant related food safety standards, tools, and training programs by incorporating inputs both from internal teams and external expert sources to ensure compliance through effective communication
Project and advocate Yum!’s position at meetings with government, trade/research associations, academia, and industry
Advanced degree in life science related field
3-5+ years of experience in food industry, government or related industry in a similar role
Working knowledge about federal, regional and local food regulations
Excellent people and communication skills to facilitate interaction with regulators, external experts and internal teams

143

VP, Quality & Regulatory Affairs Resume Examples & Samples

Provides overall direction and management of the quality and compliance function that supports all Radio-Pharmaceutical manufacturing and all contract manufacturing sites that manufacture products for Cardinal’s NPS group
Is responsible for all quality and compliance functions including but not limited to: FDA inspection management and response, site and regional quality management, microbiology management, change control, supplier management, management review, development of quality policies and practices, training, and records management
Provides advice, guidance and training to Quality and Compliance staff in the execution of their duties
Interacts with regulatory agencies, as necessary
Establishes and implements policies and procedures related to quality, compliance and microbiology and ensure that the procedures are properly followed and adequate for their intended use
Establishes implements and monitors quality performance measures for the site
Interacts with and provides advice to management and other personnel in the establishment of systems, plans, specifications, methods and procedures
Assess data collected (complaints, investigations, change control, stability failures, etc.) to identify trends and develop corrective actions where needed to ensure compliance with cGMP’s and regulatory requirements
Lead the periodic management review meetings
Maintain communication with key business leaders to ensure complete awareness of relevant issues
Escalates significant regulatory issues to senior management
Recruit and retain talented and diverse leaders with a robust succession plan
Provide overall oversight of regulatory compliance for all manufacturing sites
Excellent interpersonal, organizational and communication skills
Demonstrated leadership and the ability to motivate others
Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.)
Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices in the cGMP regulatory field
B.S. in a science related discipline (Chemistry, Biology, Engineering). A higher degree preferred
10-15 years of experience in the pharmaceutical / medical device / biologics industry
Minimum of 10 years of experience in a quality management role
Thorough knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and quality system requirements
Extensive experience dealing with FDA in inspectional situations and response activities
Working knowledge of microbiological principles and practices in the pharmaceutical industry

144

Regulatory Affairs Resume Examples & Samples

Serves as an Associate RA representative on project teams
Supports senior Regulatory personnel in preparing new product marketing submission for the FDA (510k, PMA)
Maintains Regulatory Affairs documentation
Supports international Regulatory requests
Sends out notifications of change to the Notified Body as required
Supports divisional and corporate litigation requests as needed
Assist in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements
Performs on special projects as required
Bachelors Degree in Life or Engineering Science, Business, or equivalency
No previous regulatory experience is required
Good writing and strong organizational skills required
Demonstrated communication and human relation skills
Ability to plan and schedule multiple priorities in a concurrent fashion
Ability to review, collate and summarize scientific and technical data
Excellent problem solving and analytical skills
Good written and oral communication skills
Ability to work well within cross-functional teams
Complete work with minimal supervision and ability to work independently

145

Associate Specialist, Regulatory Affairs Resume Examples & Samples

A Bachelor’s degree required (Scientific discipline preferred) 1 year previous RA related experience required
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Good knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Good knowledge and understanding of global regulatory requirements for new products or product changes
Good knowledge of new product development systems
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
Ability to build stable working relationships internally

146

Manager, Government & Regulatory Affairs Resume Examples & Samples

Contribute to the development of a long-term and comprehensive government and regulatory affairs strategy that supports the evolution of the Company’s commercial activities and long-term sustainability
Identify regulatory threats then develop regulatory positions to drive effective engagement with elected government officials, bureaucrats, representatives from other government institutions, and key third-party influencers
Drive the development and execution of strategies, initiatives, and plans to address current and future regulatory issues, with input from relevant divisions/functions
Develop integrated campaign plans mobilizing external stakeholders, industry partners (local and global), media, and employees to advocate preferred regulatory solutions
Identify and build relationships with key external stakeholders (government, NGOs, public health, community) to support the achievement of preferred regulatory and business outcomes

147

Case Manager, Law-regulatory Affairs Resume Examples & Samples

Responsible for oversight of litigation portfolio of loans comprised of contested foreclosures, bankruptcies, evictions, code violations, tax/HOA matters, probate, title and lien releases, etc
Review the pleadings associated with contested matters
Conduct legal and factual analysis of loans in case portfolio
Review external counsel legal analysis of cases and provide feedback, questions and guidance in relation to case strategy
Complete legal analysis of potential loss due to litigation and provide formal recommendations to management to reduce expenses and mitigate losses in conjunction with external and internal legal recommendations
Manage litigation proceedings on assigned case portfolio by interacting with assigned default counsel, Attorney Relationship Managers and the appropriate Business Units
Collaborate with internal and external counsel and Business Units in implementing solutions
Review of Ombudsman responses to CFPB and Regulatory complaints
Coordinate/perform escalated research on litigated loans, such as the application of payments, proper foreclosure notification, who to foreclose in the name of, compliance with confirmed plans and discharge orders, and any other situation that may arise
Monitor external attorney’s performance by reviewing the litigation pleadings, proceedings, records and timeframes
Recognize legal issues and deviation from accepted practice and address these issues with internal and external counsel
Track status of pending litigation by updating all systems/databases
Provide oversight of all Litigation matters to completion
Assist other Case Managers
Escalate all complex litigation, class action suits and risks to management
Assist with special projects/duties as assigned
Conduct a complete review of the litigation file to ensure all default servicing and/or court timeframes are met
Request and review all updated documentation from investors, insurers, and agencies to ensure compliance
Diligently check status on all outstanding requests and telephone calls from internal and external counsel and Business Units

148

Manager of Regulatory Affairs Resume Examples & Samples

Prepare and contribute to the preparation of regulatory submissions for both domestic and international regulatory authorities
Interact with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review
Minimum 5 years’ hands on experience in Regulatory Affairs specific to orphan drugs, Medical Devices and/or biotechnology companies
Must be familiar with FDA requirements and EU regulations as related to subject matter
PhD(or in progress) required with 2+ years successful experience leading a team responsible for drug and/or device submissions

149

Regulatory Affairs Office Resume Examples & Samples

May act as a Lead Regulatory Professional or Project Manager on any type of writing or technical project and may provide strategic regulatory or technical consultancy
Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges that are acceptable to Quintiles and customers, thereby consistently receiving positive customer feedback
May design training materials and deliver training externally and internally
Perform other duties, as business needs require
Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff
Sets a positive example to staff, relating to professionalism, attitude and interaction with colleagues and customers
Demonstrates confidence and appropriate communication style in representing staff issues or concerns to senior management

150

Regulatory Affairs Advocate Resume Examples & Samples

Seven years of experience analyzing and interpreting regulations, legislation, or policies
J.D. or Master’s Degree
10 years of regulatory affairs/legal or other relevant experience; experience analyzing and interpreting regulations, legislation or policies in a public utility or other regulated environment
Experience interfacing effectively with external stakeholders, regulatory agency staff, corporate officers, and all levels of management
Experience developing, implementing and monitoring multi-year strategic plans to promote advocacy
Experience developing testimony, legal filings, and other regulatory reports

151

Advisor, Regulatory Affairs Resume Examples & Samples

Lead or prepare portions of US, EU or international product registrations for a range of globally regulated cardiology and endovascular products
Lead and/or participate in project team meetings as a regulatory representative
Coordinate and compile regulatory submissions, including preparation and maintenance of Certificates of Foreign Government and required legalization activities
Initiate, review and approve Documents Change Order requests, CAPAs, etc
Maintain a well-organized and efficient filing system of regulatory records
Maintain information in various compliance databases and produce reports, as needed
Ensure compliance with regulations and guidelines as well as company SOP’s and protocols
Some travel 5-10%, possibly international, may be necessary
Some international conference calls, outside of normal working hours, may be necessary
Bachelors’ degree in related discipline and 4+ years related experience in health-care related industries (pharma, IVD or medical devices)

152

Principal, Regulatory Affairs Resume Examples & Samples

Serve as the lead for international regulatory engagement and advocacy
Translate Brocade's Wireless BU technical and business goals to specific regulatory positions
Understand the various NRAs with which Brocade is engaging; the key decision makers, processes, etc…
Formulate both an overall strategy and a specific tactical advocacy approach for each of the NRAs
Monitor new wireless and spectrum activity (e.g. rulings, notices, consultations, etc…) within their geographic area and initiate action where appropriate
Participate in, and possibly lead, regulatory and policy activities within various SDOs and ITOs
Work collaboratively within the broader regulatory and standards team to help align strategy
Communicate effectively and proactively with other Brocade groups (e.g. Engineering) to coordinate and inform regulatory activities
Excellent English written and verbal communication skills
Strong presentation skills with ability to translate technology into compelling language for regulatory and policy audiences
Preferred location for this position is UK

153

Legal & Regulatory Affairs Executive Resume Examples & Samples

Review all commercial contracts/document to ensure compliance, minimize commercial risks and protect the Company’s interests
Provide strategic and risk management counselling towards dispute resolution & manage litigation tasks
Advise internal clients across company’s business on day-to-day legal issues
Facilitate projects / new concepts fruition which involve legal implications to minimize risks and defend commercial interests for the Company
Monitor and track market intelligence and the regulatory environment in Taiwan. Provide regular update on the market insights and implications
Facilitate the formation of internal positions on specific regulatory issues and ensure necessary pre-caution/measures are well considered
Involve and contribute the Company’s input to the industry platform and ensure the Company’s positions and interests are well represented
Bachelor of Law degree or above or L.L.M. degree from accredited U.S. law school
Minimum 2 years law firm experience required
Above average English capabilities in reading, writing and listening
Above average legal research abilities
Above average PowerPoint skill
Common sense, great judgment, and a good sense of humour
Ability to work alone

154

Prudential & Regulatory Affairs Resume Examples & Samples

Providing timely and accurate advice on APRA's requirements and expectations
Reviewing new business, product and transaction proposals across Macquarie for compliance with prudential standards for authorised deposit-taking institutions
Liaising with APRA, including approval requests, reviews of Macquarie's operations by APRA, and proposed new prudential rules or changes to prudential regulation and policy
Assisting drafting, reviewing, updating and implementing group wide policies, procedures and guidelines
Influencing, and participating in, group wide projects and strategic planning, including on reform of banking regulation; and
Educating business and support groups on APRA standards, guidance and expectations, as well as changes to the prudential framework

155

Advisor, Regulatory Affairs Resume Examples & Samples

Strategize and prepare domestic and international regulatory filings such as 510(k), IDE, PMA, Annual Reports, and Design Dossier submissions, including subsequent revisions/supplements and amendments
Represent regulatory function on project teams and provide input on regulatory strategy
Communicate with domestic and international regulatory bodies
Review and approve advertising and promotion materials in compliance with FDA regulations and guidelines
Review and approve Engineering Change Requests, CAPAs, NCRs, and Complaints
Maintain information in various compliance databases and produce reports as needed
Ensure compliance with FDA and EU regulations including relevant company SOPs and protocols
Support internal and external audits as needed
Manage a well-organized filing system of all regulatory files
Bachelor’s degree or higher in a relevant technical or scientific field is required
4+ years of experience in regulatory submissions required
Experience in direct communication with regulatory agencies
Prior experience as a project leader with strong project management skills
Advanced degree and/or regulatory affairs certification (RAC) preferred
Excellent written and oral communication skills; technical writing capabilities are a must
A hands-on, decisive, action-oriented style preferred

156

Head of Legal & Regulatory Affairs M/F Resume Examples & Samples

Protect and support Danone's business, innovations and assets by ensuring the optimal legal and regulatory framework (including contracts, sales and distribution, consumers, advertising and promotion, products, company law & regulations, intellectual property & media, dispute resolution, competition law & anti-trust, advocacy and trends follow up)
Act to break silos across Categories and ensure One Danone Voice consistency in the clusters
Manage, animate, lead, help grow and empower a network of experts in legal & regulatory affairs
Coordinate compliance activities & policies implementation

157

Regulatory Affairs Lead Benelux Consumer Healthcare Resume Examples & Samples

Masters degree in pharmacy or Life science
Min 7y experience and a profound knowledge of regulatory requirements relevant for the categories relevant for the company
Understanding and application of life science
Proven to be successful in the relevant regulatory environment
FLuent in English and French; a good command of Dutch would be an asset
Products and portfolio: Products are across several legal categories, such as medicinal products (Over the counter (OTC), prescription medicines (Rx)), cosmetics, medical devices (Class I, class IIa and IIb or even Class III) and other consumer products that have no special legal category (e.g. toothbrushes)

158

Regulatory Affairs Director Resume Examples & Samples

Bachelors degree in chemistry, biology, biochemistry or similarly applicable discipline
10+ years significant experience in regulatory affairs, or appropriate relevant experience in scientific function in vaccine industry combined with at least 4 years direct RA experience ((or advanced degree and 10+ years experience)
Requires scientific and regulatory knowledge pertinent to all stages of product development
Direct experience in clinical regulatory affairs as well as CMC regulatory affairs for licensed biologic product or vaccine is essential
Operational knowledge of IND and NDA/BLA regulations and other relevant US regulations pertinent to product development and licensure,
Understanding of scientific basis for clinical development, endpoints, and product CMC is critical to role
Direct experience as liaison with US FDA
Prior experience with biologics or vaccines is required
Strategic Leadership – Experience in providing strategic advice on integrated regulatory development plans and life cycle management, preferably for the US. Providing US-focused input into regulatory strategy, evaluating potential impact on overall project/product strategy. Leveraging internal and external regulatory and scientific networks to problem solve. Providing input into corporate regulatory positioning including US key considerations early in the product development. Writing/critically reviewing, while ensuring rigorous scientific content/quality/compliance, key documents targeting internal or external key audiences, including but not limited to annual reports, status reports on post marketing requirements/commitments related to clinical safety, clinical efficacy, or clinical pharmacology, briefing documents, key meeting summaries, and BLA modules
People & Program Management – Identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving. Developing plans and timelines for complex projects and collaborating with other departments and teams in the delivery of outputs in a timely manner. Forming collaborative relationships and having high impact and influence on multicultural, diverse, and/or international teams. Ensuring that a corporate or departmental regulatory voice is clearly articulated and heard consistently and concisely in various cross functional teams
Enterprise thinking – Understand the constraints and drivers of other functions and the potential impact on regulatory affairs World-wide, including how regulatory affairs may facilitate in achieving the overall corporate goal
Proactive leadership – Identify issues and maximize opportunities. Quickly assimilate facts and data and develop an understanding of complex matters with the ability to translate this understanding as part of developing, mentoring, and coaching junior staff
Participate in project/product-related discussions and provide strategic, scientific and regulatory input, for FDA specific aspects of given project topline and in depth on clinical/labeling, CMC/NC, advertising and promotion and/or procedural aspects
Provide input into the asset specific regulatory strategy for US
Serve as the point of contact for FDA for specific products and development programs. Ensure professional and collegial relationship, applying best practices for each program assigned
Provide input into the Global Regulatory Plan (GRP) for US specific aspects of (clinical/labeling, technical/NC and/or procedural) sections
Compile/write/review high quality project/product specific regulatory documents to be submitted to FDA (for clinical/labeling, CMC/NC and/or procedural) and ensure that those documents meet regulatory requirements
Provide input to Vaccines Development Plans in order to optimize the US label and secure proper alignment of CMC/NC and/or clinical/labelling. Assure use of appropriate regulatory procedures to secure the optimum submission strategy and achievement of US commercial promotional goals
Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; accountable for execution for US clinical/labelling, CMC/NC and/or procedural RA aspects
Stay current with changes in regulatory guidelines and rules, understand and communicate their impact on regulatory strategy for the particular asset(s); advise project teams on how best to address changes
Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the FDA
Ensure planning and proper organization of US activities in line with the overall project plan and RA milestones; Raising risks (such as gaps in resource) for resolution within global teams and to NARA leaders
LI-GSK

159

Category Regulatory Affairs Senior Manager Resume Examples & Samples

BS/BA degree in a scientific discipline
8 year experience within Regulatory Affairs
Extensive knowledge of US regulations
Extensive knowledge of US regulations for OTC/Rx drug products
Experience with Rx-to-OTC Switch regulations
MS/Ph D/Pharm D/JD
Significant experience with US Rx-to-OTC switch, including preparation for
Acts as a Business Partner and provides regulatory advice to a project on aspects of drug/ device development as appropriate
Develops regulatory strategies working within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams
Communicates effectively with the immediate functional team and within cross-functional Project Teams
In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc with supply chain and technical excellence Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions
Skilled organizer and communicator due to the complex mix of internal and external relationships
Can work independently with senior external stakeholders, with ability to represent category position and make necessary decisions without constant reference to center
Ability to manage in a network/matrix (i.e. to co-ordinate activities of a wide range of GSK staff/disciplines with no direct reporting line) to achieve and operate to consensus
Driven, self-reliant and flexible, with excellent time management skills and an ability to work in an empowered environment
Sound influencing and negotiating skills
Track record of influencing change
Demonstrated ability to apply sound scientific principles, techniques and decision making in driving their assigned programs
Able to create business solutions
Responsible for highlighting own development needs and work with his / her manager to prepare a development plan and achieve development goals
Substantial record of achievement in previous role/s

160

Regulatory Affairs Executive Resume Examples & Samples

Develop registration strategies, submit new product registration and perform regulatory activities during the lifecycle management of a product
Perform quality activities such as batch release, handling of product complaints and recall according to external regulations and company policies
Ability to communicate effectively with internal and external counterparts
Analytical and proactive problem solving abilities

161

Regulatory Affairs Principal Resume Examples & Samples

Prepares robust regulatory applications to achieve departmental and organizational objectives
Creates, reviews, and approves engineering changes
Provides leadership and guidance (including training) to other members of the RA staff
Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations
Independently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies)
Builds strategic partnerships to further departmental and organizational objectives
Reviews of product and manufacturing changes for compliance with applicable regulations (Change Control)
Reviews protocols and reports to support regulatory submissions
Assesses proposed regulations and communicates new requirements to the organization
Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Assists with audits and inspections, if required
Performs other related duties and responsibilities, on occasion, as assigned

162

Regulatory Affairs Operational Coordinator LAS Resume Examples & Samples

Coordinates the implementation of studies required by any authority of LAS
Develops together with the Lead for Regulatory Affairs of the country the best response to the concerns or comments from authorities, customers, etc .; related to waste in food, drinking water, toxicology, ecotoxicology, environmental fate and physico-chemical properties
Informs Product Safety / Chemicals LATAM the concerns or observations of authority that he cannot not solve and coordinates with them and with the Lead for Regulatory Affairs the most appropriate response
Ensures that the guidelines on Syngenta's information security (Intellectual Property) are met in LAS
Coordinates the maintenance of the updated Regulatory Affairs management systems (Trackwise, Boundless)

163

Senior Analyst Regulatory Affairs Resume Examples & Samples

Assure integrity of the design history file and technical file prior to regulatory filings
Draft reports to regulatory agencies
Regulatory Responsibility for the compliance lifecycle management for products/projects assigned to him/her
Working closely with the R&D Teams assessing regulatory implication of design changes
3-5 years in IVD/Medical Device related industry
Experience with regulatory agencies (such as FDA, BfArM, MHRA)
Experience with Project Management
Knowledge of ISO14971, IEC 61010, IEC 60825, IEC 62366 and IEC 62304
Experienced interaction with regulatory agencies
Good awareness of FDA & 21 CFR part 820 Quality System Regulation
Qualitative and quantitative analytical skills
Clean driving record – ability to travel as required (may include international travel)

164

Chief Regulatory Affairs Counsel Resume Examples & Samples

Identify new opportunities to achieve CSPI’s goals through regulation and legislation
Oversee regulatory initiatives on food labeling, food additives, and related issues
Plan, organize, and execute legislative, regulatory, and other strategies to achieve public policy goals
Draft major reports, petitions, complaints, comments, speeches, and court briefs to attain program goals
Develop and coordinate coalitions of health and consumer organizations
Cultivate relationships with top officials of the FDA, FTC, and USDA to advocate public-policy goals
Work with congressional offices, state attorneys general, and trade association executives
Represent CSPI at national conferences and public hearings
Coordinate with CSPI’s litigation team and other staff members in crafting strategies
Handle press inquiries and interviews
Demonstrated commitment to public-interest advocacy and consumer protections
Law degree (J.D.), and at least 10 years of legislative or regulatory advocacy experience. Health/science knowledge a valuable plus
Demonstrated knowledge of consumer and regulatory law, especially pertaining to food
Strong legal writing, research, and verbal communications skills, including public presentations
Ability to read, analyze, and interpret legal, financial, and scientific documents
Demonstrated knowledge of the legislative and regulatory processes

165

Regional Regulatory Affairs Resume Examples & Samples

Experience with interacting with the FDA (i.e., OPDP, APLB, or Office of Compliance)
Must have exceptional organizational skills and knowledge of FDA regulatory requirements and enforcement history
Demonstrated experience practicing sound judgment as it relates to promotion risk assessment
Ability to identify the ‘big picture’ and opportunities/major issues and link day to day tasks with long term goals
Success in project management and working in a collaborative team-based environment
Proven ability to deliver to successful outcomes to internal and external customers while meeting business objectives

166

Regulatory Affairs Engineer Resume Examples & Samples

Support and provide regulatory expertise to assigned product development projects from technical approach to post marketing phase
Create and execute Regulatory Strategies and Plans for assigned products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
Prepare and submit 510(k)'s, IDE's and other product submissions according to FDA guidelines
Create European Technical File and Declaration of Conformity documents (MDD, R&TTE, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines
Review and approve product labeling plans, labeling, and marketing communications
Support the international regulatory team with inputs, as needed, into the registration packages they prepare
Support internal and external quality audits; participate as a member of PMRA and CAPA teams for Corrective and Preventative Actions

167

Regulatory Affairs Publishing Associate Resume Examples & Samples

Preparation of submission files compliant according to appropriate ICH and regional guidance
Bookmarking/hyper linking as per the requirements
Optical Character Recognition (OCR)
Archiving (paper and electronic), as applicable for innovator molecules, branded therapeutics, generics and API
Troubleshoot technical issues in MS Word and Adobe Acrobat documents
Keeping abreast with regulatory guidance’s

168

Regulatory Affairs Assistant Manager Resume Examples & Samples

Lead Regulatory Affairs’ PC category by ensuring all aspect of regulatory compliances to government regulations (e.g. Food and Drug Administration (FDA)
Provide strategic regulatory recommendation and guidance throughout the project network
Monitor regulatory development and assess their impact to the business based on advanced interpretation of the upcoming regulation guidelines and work effectively with team for implementation
Assist Regulatory Affairs advocacy initiatives by developing strategic plans supporting product innovations
Effective collaboration, liaising and company representation to key regulatory partners (e.g. FDA)

169

Manager, Government & Regulatory Affairs Resume Examples & Samples

Develop and maintain an on-going, positive relationship with legislators, regulators and other government officials. · Favorably represent Frontier and effectively advocate its positions with key stakeholders and others in the industry. ·
Monitor and interpret regulatory orders and legislation to identify compliance requirements, business opportunities, and threats. ·
Communicate legislative and regulatory opportunities and threats internally to impacted management and impacted groups within the organization, coordinate development of a necessary advocacy strategy, and execute advocacy strategy effectively to take advantage of opportunities and mitigate threats. ·
Develop and oversee procedures designed to maintain an on-going awareness of and compliance with all state rules, laws and agency orders applicable to telecommunications carriers and effectively guide Frontier through legal and regulatory obstacles to its product and financial goals. ·
Provide guidance to Frontier leadership on issues involving state regulatory and government matters
Bachelor of Science in Business, Finance, Economics or related field
Graduate degree preferred
5+ years of relevant experience preferably with government relations
Ability to work independently and successfully address multiple priorities
Strong management, written and verbal communication and presentation skills
Ability to work well with cross-functional teams, ability to understand complex legal and regulatory documents
Ability to develop positive relationships within the industry and with Frontier’s business partners

170

Senior Analyst, Regulatory Affairs Resume Examples & Samples

Bachelor’s degree with at least 4 years of professional experience in the medical device industry is required
Thorough knowledge of FDA and international regulations pertaining to the design, manufacture and commercialization of medical devices is required
Demonstrated proficiency with worldwide regulatory planning/strategy and submission planning/preparation is required
Proven proficiency with PC-based productivity applications, including Microsoft Word, Excel, PowerPoint and Project is required
Experience in project team participation and domestic submissions is required
Strong regulatory and clinical writing skills required
Demonstrated ability to analyze complex regulations and guidance documents is required
Advanced degree in a related field is preferred
A basic understanding of sinus disease and treatments is preferred

171

Compliance Analyst Iii Regulatory Affairs Resume Examples & Samples

Bachelor's degree in finance or related field
Minimum 5 years' experience in the financial Services Compliance Regulatory Affairs Industry
Series 7, 63 preferred. Opportunity to obtain additional licenses
Familiarity with SEC, FINRA, MSRB rules/regulations, industry practice and how they apply to Stifel and affiliated firm policies and procedures
Demonstrated skills in organization, strong attention to details, prioritizing and managing time, multiple tasks and varying priorities in order to meet critical deadlines
Developing, and maintaining constructive and cooperative working relationships with others, and sustaining them over time
Able to gather information from research, existing documentation and subject matter experts, and effectively explain complex ideas to technical and non-technical audiences

172

Regulatory Affairs & Quality Assurance Coordinator Resume Examples & Samples

Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field)
Review development quality reports and plans to ensure that the information required for submissions is adequate
Plan, generate, and coordinate regulatory submissions for product/solution licensing
Coordinate testing required to support regulatory submissions
Review and approve product/solution labeling and product/solution-related marketing communications (generally at BIU and Field)
Maintain existing regulatory filings/ licenses, managing updates and related change control processes (generally at the BIU and field level)
Improve existing processes
Act as a supervisor when needed

173

Regulatory Affairs Investigator Resume Examples & Samples

At least five years of Maintenance experience on large transport category aircraft
Aviation maintenance supervisory and/or investigative experience is preferred
Physically this position requires the ability to speak, hear, walk, and remain seated for long periods of time
Must possess extensive computer skills
Must be well organized with excellent verbal and written communication skills
Candidate must be able to assimilate technical data for verbal and written response to regulatory authorities
Must work under time constraints to accomplish assignments and projects by assigned deadlines
Must be able to work well as part of a team and have the ability to handle complex issues in a fast paced environment
Must maintain confidentiality of proprietary information handled in daily tasks
Must have working knowledge of the Federal Aviation Regulations with strong emphasis on part 121 operations
Must be able to travel and stay overnight occasionally which could include part of a weekend to support initiatives of the department

174

Office Manager Federal Regulatory Affairs Resume Examples & Samples

Assist with advancing policy strategy and advocate the interests of the Company, its customers, and its stakeholders. Protect and advocate the Company's interests regarding current or future proposals that could have material impacts
Develop and maintain excellent relationships with staff and coordinate/manage regional relationships
Exercises significant latitude in determining and executing objectives and approaches to critical assignments
Strong analytic and advanced financial modeling skills with advanced knowledge of MS Word Excel, Power Point, Access and SQL
Experience in corporate budgeting, forecasting, and financial analysis
Devises methods, modifies or adapts standard procedures to meet different situations
Contributes to the establishment of the organization’s strategic goals
Directly impacts goal achievement of complex company-wide or interdepartmental projects with strategic importance
Partnering with the business to continually understand key business issues and develop reporting and analysis to enable success in the business
Serves as liaison on specific projects in other work areas and/or with customers, suppliers, government/regulatory bodies, etc
Lists: Create and maintain office phone lists, FCC leadership lists, etc
Travel: Make travel arrangements for VPs and maintain travel profile in CONCUR
Budget preparation, monitoring and liaison with CenturyLink Vice President Federal Legislative Affairs and Policy, Director Legal Operations and Administration and Finance Department
Developing and preparing monthly and quarterly management reporting for use by the executive team
Accounts Payable: process invoices and expenses via SAP and CONCUR. Ensure that all invoice and expenses are valid and correct. Reconcile any expense discrepancies. Maintain accurate records. For Sponsorships/Contributions: coordinate with Corporate Communications to get invoices processed, as requested/approved by VPs. Maintain accurate records of sponsorships/contributions
Coordinate and manage departmental IT requests and needs
Real Estate: On-site point of contact with building management and engineering and real estate company. Liaison with CenturyLink Real Estate (including lease, furniture, artwork issues)
Parking: Liaison with parking vendor. Add and drop parkers as needed. Process invoice payments via SAP. Current vendor does no email invoices; sent by USPS. Once a new contact is established, invoices can be seen/printed online
Subscriptions. Process subscription renewals. Pick up daily newspapers/publications at lobby attendant station
Supplies: Order and maintain all supplies inclusive of coffee, water, copier and printer supplies
Security & Access: Assist guests and visitors. Manage access and security needs. Liaison with CTL Security for badges, including security badges for building staff/cleaners. On-site contact for corporate shred service
New/Departing Employees - On-boarding assistance for new employees and exit assistance for departing employees. On-boarding includes computer and phone setup, security access, ordering business cards, assistance with expense processing/CONCUR, etc
Postage: Open a Stamps.com account. There is a monthly fee. Postage can be purchased and stamps/postage printed for regular, mail parcel post and priority mail. I have cancelled my Stamps.com account since it is linked to my email and corporate card
Mail: Pick up and distribute mail. Each staff member has a mailbox key. Mail is delivered after 4pm each day. This is inclusive of maintaining shipping supplies, courier accounts and needs for the department
Conference rooms, kitchen and departmental common areas must be maintained and in good order. Keep information on WiFi other technical information up to date
Bachelor's degree or the equivalent in relevant training, education and experience
Minimum of five years of experience within the telecommunications industry
Minimum of eight to ten years of experience in a federal government affairs environment
Must demonstrate a high degree of integrity due to the nature of information involved and the visibility
Must demonstrate the ability to make persuasive and effective presentations
Must demonstrate the ability to employ tact and diplomacy to foster amicable business relations with a wide range of individuals, within and outside the Company
Excellent verbal and written communication skills and analytical abilities
Fifteen to twenty years of experience in a federal government affairs environment

175

Project Leader Regulatory Affairs Resume Examples & Samples

A minimum of a Bachelor’s degree is required, preferably in a biological/life sciences or engineering discipline
6+ years of Regulatory Affairs experience in a regulated healthcare environment or industry; or minimum 4 years with advanced technical degree is require
Experience with US FDA Regulations and European Medical Device Directives required
Experience in worldwide regulatory systems preferred
Demonstrated expertise in medical device regulatory requirements and processes required
Demonstrated expertise in orthopaedics and orthopaedic device regulatory requirements preferred
Outstanding project management skills by demonstrated competence in managing multiple projects simultaneously required

176

Attorney, Regulatory Affairs Resume Examples & Samples

Providing day to day legal support and counseling to internal clients regarding regulatory compliance, especially with regard to NHTSA and CPSC standards, regulations and reporting requirements; and similar obligations with regulators in international markets
Representing Polaris before government agencies, especially NHTSA and CPSC, in regulatory enforcement proceedings, rulemaking proceedings or policy development meetings
Representing Polaris on industry association working groups
Developing a strong working relationship with the relevant staffs at NHTSA and CPSC
Ensuring that internal clients are aware of impending changes in regulations and laws that affect the company’s business operations and reporting obligations
Working with Polaris’ engineers, quality specialists, lawyers, paralegals, and other business units as needed
Consulting with outside counsel as needed
J.D. from an ABA accredited law school Admission to bar and good standing in jurisdiction of primary working location (MN or DC)
Two plus years of experience in regulatory law Interest/background in technical/engineering aspects of vehicle manufacturing
Ability/desire to work hard in a lean in-house legal department
Experience with and knowledge of the Consumer Product Safety Act (and associated regulations)
Experience with and knowledge of National Traffic and Motor Vehicle Safety Act (and associated regulations)

177

Legal & Regulatory Affairs Advisor Resume Examples & Samples

Develop Ryanair’s EU General Data Protection Regulation compliance system
Manage court and administrative proceedings across several jurisdictions
Engage with authorities on consumer protection and unfair competition law matters
Draft and review legal submissions, briefs and correspondence
Interact with and manage outside counsel

178

Group Of Regulatory Affairs & QA Manager Resume Examples & Samples

Develop regulatory strategy and provide decision making necessary to ensure successful regulatory submissions and ontime marketing authorisation approvals of new products, variations, and renewals
Provide strategic advice to project teams and senior management regarding current and emerging regulatory requirements to determine potential impacts on organizational processes
Develop strategy and implementation plan for external communication review process to ensure external communication (promotional and non promotional) materials comply with regulatory, legal, and scientific requirements
Establish a company quality assurance system by ensuring and monitoring the implementation of Good Manufacturing and Distribution Practices to improve product quality and customer satisfaction
Ensure ongoing regulatory compliance by leading the development, implementation and monitoring of Regulatory and Quality Assurance procedures, policies, and practices

179

Senior Associate Biological Regulatory Affairs Resume Examples & Samples

Assist with regulatory support for multidisciplinary Project Teams responsible for developing veterinary biological products
Assist in the preparation of US 103.3 regulatory submission assembly and followup
Circulation and tracking of Phase III/IV Risk Assessments
Circulation and tracking of MS/MC reports, Outlines of Production/Special Outlines, and SIFs
Circulation and tracking of Production Outlines, Special Outlines and required supporting documentation
Liaise with international regulatory staff to support global registration where appropriate 7. Maintain current knowledge of CVB regulations
Participate in standing department meetings to stay current on RA team priorities and activities
B.Sc. in biology, animal science or other related science
MSc, DVM or equivalent is desirable
A minimum of 3 years’ experience with veterinary biological products, preferably in regulatory affairs or a related area; or comparable clinical experience
Strong verbal and written communication skills, and a demonstrated ability to work in a team environment
Understanding of the veterinary biological development process and USDA regulatory requirements desirable
Knowledge in the production and testing of veterinary biological products desirable

180

Associate Director Commercial Regulatory Affairs Resume Examples & Samples

Review and provide strategic regulatory advice on advertising and promotion materials and activities, including high level concepts, press releases, campaigns, HCP materials, consumer materials, and disease and institutional materials for assigned products and for the overall therapeutic area, in accordance with business goals and objectives
Ensure advice provided appropriately balances benefits and risks and is solution oriented taking into account BMS guiding principles, applicable FDA regulations and guidance’s
Understand the review process, including providing strategic solution oriented advice with risk assessment in addition to understanding when escalation is necessary
Foster utilization of BMS guiding principles to help guide your discussions with Commercial colleagues in order to ensure understanding of advice provided
Provide risk assessment to management on marketing and medical initiatives and solutions to help mitigate risk
Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals
Build strong collaboration with matrix teams, including Commercial, Medical, legal and commercial regulatory colleagues in order to provide robust strategic advice
Proactively engage and collaborate with Commercial teams to understand and help provide strategic regulatory advice on business issues
Ensure that changes in US PI are reflected in current promotions and advertising, as well as, updating/revising important safety information as needed
Monitor US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies and by attendance at major industry/FDA meetings
Provide strategic regulatory advice and guidance on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
Build a strong relationship with OPDP and propose regulatory submission strategies for OPDP to Commercial teams
Ensure timely and accurate submission of promotional materials to OPDP on Form 2253
Liaison with OPDP regarding product promotion as necessary
Prepare communications to OPDP concerning the company's proposed advertising, identified competitor practices, OPDP inquires, and other notifications
Provide training in FDA regulations and guidances for advertising and promotion to employees, agents of BMS, and Alliance Partners
Handle other duties and/or special projects as assigned
Bachelors degree required; advanced degree preferred (MS, PhD, PharmD, or JD)
Greater than 3 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical promotional review)
Experience providing strategic direction to interdisciplinary teams on promotional materials activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)
Experience in providing solution oriented regulatory advice and guidance
Proven ability to analyze and scientific data
Exposure to OPDP interactions related to promotional activities
Good interpersonal and communication skills; able to easily adapt to change, ability to interact with individuals, teams, across matrix partners

181

Regulatory Affairs Consultant Resume Examples & Samples

Life Science Degree or higher with at least 5 years experience in a research / pharmaceutical company environment or in a regulatory agency or equivalent
Ability to exercise independent judgement in developing methods, techniques, and evaluation criteria for obtaining positive results in a regulated environment
Demonstrated success in scientific creativity, collaboration with others and independent thought
Extensive knowledge of regulations relevant to drugs or biologicals, relating to area of expertise
Comprehensive understanding of the drug development process
Must possess very good negotiating skills and the ability to communicate effectively in both oral and written modes

182

Scientific Regulatory Affairs Asean Compliance Manager Resume Examples & Samples

Managerial Competencies & Skills
Ingredients expert in the aspects of formulation, ingredient benefit and safety also prefer
Food Safety Regulatory Competencies
Influence and Negotiation
Drive Innovation
Competent/Proficient in understanding the regulatory environment and processes in different countries in ASEAN
Keep abreast of the latest local regulation in every country on food safety registrations
Proficient in several software applications packages such as: Excel, Word, Sales Force, SAP and PowerPoint
Close follow-up to meet deadlines on time, even dealing with government agencies
Good interpersonal relations in order to give support to others as well as to lean on appropriate offices: in other Divisions, Legal counsels, bottlers, field offices or government

183

Director, Commercial Regulatory Affairs Resume Examples & Samples

Serving as CRC Chair to moderate purposeful discussions in a solution-orientated and time-sensitive manner, swiftly leading the committee to consensus on the approval of materials or the need to escalate, ensuring that CRC members uphold the Eisai values during CRC meetings and other CRC-related activities, and fostering close collaboration with the Business Owner to optimize the quality of the materials and accelerate their review and approval
Ensuring highly effective and efficient review and approval process for advertising and promotion materials and the timely and accurate submission of branded materials to FDA in compliance with FDA regulations
Leading the development of best practices and procedures for CRCs including the maintenance of the CRC SWP to ensure the consistency, accuracy and quality of the advertising and promotion review and approval process
Ensuring a robust training program on the advertising and promotion review and approval process is implemented for all CRC stakeholders, as well as support training on the regulatory requirements for advertising and promotion review and approval and the regulatory landscape
Reviewing and approving all advertising and promotional materials, concept reviews and pre-commercialization materials for assigned products in collaboration with commercial, clinical and legal to ensure that they comply with FDA regulations. Providing strategic input into labeling as a member of core labeling development teams
Acting as liaison with OPDP for assigned marketed products to facilitate the FDA review of advertising and promotional materials (e.g. launch materials submitted for advisory)
Providing legal, clinical and commercial with updates on new FDA guidance, the issuance of enforcement letters by OPDP and other Eisai or competitor product FDA correspondence
Developing, implementing and maintaining regulatory procedures regarding review of advertising and promotional materials for marketed products and pre-commercialization materials for products or uses prior to FDA-approval
Minimum BS degree or higher in life science
>10 years in Regulatory, R&D or related area, with at least 5 years of experience in commercial regulatory affairs or equivalent experience within the pharmaceutical industry
Oncology experience a plus
Strong leadership skills with demonstrated ability to lead teams and collaborate with key cross-functional stakeholders
Demonstrated ability to manage a high workload and effectively communicate with senior management
In depth knowledge of FDA regulations and guidance documents regarding advertising/ promotion and labeling requirements
Demonstrate strong project management, problem solving, strategic thinking, decision making, conflict management, influence, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timeline

184

Senior Officer Regulatory Affairs Heated Tobacco Products Resume Examples & Samples

Work in coordination with the Manager Regulatory Affairs HTP to define and implement registration activities for PMI's HTPs in the US, according to PMI's development and launch plan
Be responsible for the preparation, compilation, quality & scientific check and publishing of RRPs submissions for HTPs in compliance with regulatory guidance/requirements in the US and PMI internal standards. Ensure completeness and accuracy of submissions to regulatory authorities in support of assessment studies, market-specific regulatory engagement activities and existing marketing authorizations
Give advice to the organization for all regulatory aspects which are of relevance to PMI's HTPs in the US. (e.g. Data Traceability, Submission Readiness & Inspection Readiness)

185

Mgr Regulatory Affairs, Facilities Resume Examples & Samples

Review Section 3.2.A for internal facilities with working knowledge to review Sections 3.2.S and 3.2.P
Write regulatory submissions, when required
Technical and Strategic

186

Regulatory Affairs Product Specialist France Resume Examples & Samples

Monitor drug regulations at the national and international levels and distributing information to the departments concerned
Provide the consolidated feedback regarding the text translation from the relevant functions in the affiliate to the EU/International Regulatory Strategist
Update all local health authority or non-health authority prescribing information / SmPC databases (where exist) and compendia (e.g Drafting monographs for the Vidal medical reference)
Liaise with marketing and commercial to ensure that all local product information used are up to date
Member of local review teams according local regulations / requirements / codes and Policy for
Review of local promotional and non-promotional materials and Risk Management Plan documents per the local promotional / non-promotional review SOP and Health Authority guidelines, as well as to check compliance with Shire standards for Global Safety Information requirements
Prepare the advertising file with ANSM and requests for any necessary copy clearances
Review logistics and content for Healthcare professional events ( local advisory boards, meetings of HCP and congress)
Provide training to medical, QA, commercial/sales team on updates and new regulations
Provide local support to the EU/International Regulatory strategists for local submission when necessary
Participate in managing ANSM requests with Local Operating Company and GRA
Participate in the drawing up and monitoring of procedures, as well as checking on their application, in cooperation with managers
Pharmacist Degree
Minimum 2 years experience in Regulatory Affairs in the pharmaceutical industry or equivalent experience
Office pack
Business English
Strong knowledge on Pharmaceutical legislation at National / European and International level
Excellent communication skills and good ability to work in teams
Professional, flexible and result oriented
Demonstrated ability to interface with Regulatory Authority

187

Scientist Regulatory Affairs Resume Examples & Samples

Support the formulation and implementation of the regional regulatory strategy for Seqirus manufactured products
Participate in the preparation and submission of high quality applications in Seqirus territories including marketing authorisation applications, variations, renewals and responses to questions
Ensure that all regulatory agency correspondence and submissions are managed within the relevant databases and tracked to ensure regulatory compliance
In collaboration with Global Strategic Labelling assist in the maintenance of up to date product labelling for all relevant Seqirus territories including translation requirements
Assist in providing Asia Pacific regional expertise for Module 1 to ensure dossiers meet content requirements for applicable territories
Assist in contributing specialist regional advice for global regulatory strategy development, especially for product development programs and complex technical changes
Establish and maintain strong and collaborative working relationships with assessors in Regions National Regulatory Agencies
A minimum of 12 months experience in regulatory affairs in any of the above industries
Strong customer focus
Commitment to achieving objectives in a complex matrix environment
Highly developed organisation skills including planning and time management
Flexibility and ability to work effectively with a range of different functional areas
Problem solving and analytical skills supported by good attention to detail

188

Lead-quality Assurance & Regulatory Affairs Resume Examples & Samples

Interact effectively with team members of Service and Sales teams in the organization
Effectively implement & manage programs and processes to meet regulatory requirements within area of responsibility
Bachelor's degree in Engineering, Medical Device Technology or Scientific Field
Minimum 5 years professional experience and understanding of quality assurance in distribution and service activities in the medical equipment or pharmaceutical industry
Business Fluency in Arabic, English, and French, both spoken and written
Ability to read, analyze and interpret business plans, technical procedures and governmental regulations
Bachelor's degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 5 years work experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment environment)
Minimum 3 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry
Ability to communicate using English
Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions, and external stakeholders
Six Sigma training and/or certification
Strong Change Management skills
Front line operational responsibility in Field Service, Manufacturing, Sourcing, or Supplier Management

189

Regulatory Affairs Team Leader Resume Examples & Samples

Work across functions including Area, PO1 (marketing) team, supply, sales and finance to develop and execute with excellence a competitive regulatory strategy
Positively engage with other functions and provide the regulatory support to enable delivery of ANZ business brand plans, Squeeze and Global Ingredient Removal projects
Develop a regulatory strategy for product categories, new products or active ingredients to bring competitive advantage to brands
Demonstrated ability to lead commercial partnership in supporting NPD/EPD pipeline and other business campaigns and strategies
Demonstrated ability to lead strategic thinking to drive commercial advantage within the regulatory environment
Ensure the registration and regulatory compliance of locally marketed products to bring competitive advantage to our brands
Amend registration/technical dossiers as necessary for country-specific regulatory requirements and submit registration applications
Negotiate with governmental authorities to obtain rapid approvals with favourable labelling and claims
Provide coaching, support and performance feedback with direct reports and technical support to regulatory colleagues
Monitor and interpret local regulatory issues and trends that will impact the marketability of company products
Liaise with local government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies
Represent company interests with local government agencies, industry associations and/or other organizations
Prepare, maintain and update local product registration and regulatory compliance files and databases
Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products
Support internal investigations into allegations of non-compliance and the activities necessary to expeditiously resolve local regulatory disputes
Provide technical support to respond to consumer and legal inquiries on regulatory issues for products marketed locally
Ensure compliance with local statutory reporting requirements
Prepare, maintain and update local product registration and regulatory compliance documentation
Work collaboratively with other functions of RB businesses providing regulatory support

190

Tech, Rates & Regulatory Affairs Internship Resume Examples & Samples

Basic writing skills are essential to this position
Must be able to communicate concisely and clearly
Must be familiar with internet searching and standard Microsoft Office software
Able to handle multiple tasks, is highly organized and detail specific
Able to manage time efficiently
Excellent interpersonal skills and the ability to work with a variety of people internally and externally
Must take initiative within established procedures
Values professional growth and learning

191

EEU Regulatory Affairs Executive Resume Examples & Samples

Postgraduate or graduate in pharmacy/biology/chemistry
Experience in Regulatory Affairs in one of EEU countries
Knowledge of regulatory policies and climate in one of EEU countries
Knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry
Insightful and forward thinking, ability to recognize, 4. Advanced level of English
Ability to work within diverse cultures and lead multifunctional matrix teams is beneficial
Identify possible regulatory issues (incl. changes in EEU requirements) and proactively communicate and escalate them, provide feasible solutions
Ensure alignment of EEU registered details with original dossiers, corporate databases and across the countries, timely update of the corporate databases
Provide support to EEU procedures development and update
Identify areas of opportunities and risks related to regulatory activities
Communicate with Regulatory Authorities and provide appropriate answers to requests from Regulatory Authorities
Lead timely submissions of post-approval commitments
Implement and comply with QMS requirements in the following processes: management monitoring (L1 Audit), deviation handling, CAPA management
Ensure regulatory support to GMP inspections

192

Associate Specialist, Regulatory Affairs Resume Examples & Samples

Complete structured regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of CMC dossiers for submission to Health Authorities [DMFs, MAFs, 510(k)’s], customer requests, etc. in compliance with regulations, guidelines and procedures
Support project development teams and communicate regulatory progress, decisions, strategies, etc., with guidance
Review assigned technical project documentation, certifications, correspondences, and external communications, as needed
Provide assistance with customer regulatory requests, including regulatory letters, compliance questionnaires, LOAs (Letters of Authorization/Access)
Develop specific objectives and manage work assignments, with guidance, in an effort to achieve personal objectives in conformance with overall business goals
Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
Challenge processes, remain open to ideas and changes to continuously improve and seek better alternatives and drive change
Adhere to all applicable government and West regulations, practices and procedures to maintain compliance
Clearly and effectively communicate team/project progress/status, decisions, timelines, etc
Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required
Education: Bachelor's in related discipline
Experience: 0-3 years or regulatory pharmaceutical experience
With an additional minimum of 3 years pharmaceutical industry experience

193

VP Regulatory Affairs & Design Assurance Kavokerr Resume Examples & Samples

Responsible for product design quality and reliability targets to meet or exceed customer expectations and to make quality competitive advantage
Develop and manage relationships with all relevant regulatory authorities and regional RA teams in connection with regulatory submissions
Promote the development of a company-wide culture of quality excellence and understanding of the key elements related to quality system
Foster and maintain strong relationships with senior RAQA Regulatory leaders across Danaher and leverage best practices and opportunities to drive cross business collaborations and initiatives
Participates in Operating Company Policy Deployment to meet business goals
Provide strong organizational leadership, ability to organize complex work, drive change and instill a culture of execution, in RAQA as well as across the broader organization
Possess strong negotiation skills, the ability to interpret and apply regulations, and working knowledge of product development process

194

VP Regulatory Affairs & Design Assurance Resume Examples & Samples

Actively participates in defining customer requirement, product claims and target markets early in the PD lifecycle
Partner with Business Unit leaders to develop prioritized product pipeline and sustaining project list that support overall business strategy
Maintain knowledge of existing and emerging regulations, standards, or guidance documents. Interpret regulatory rules or rule changes and ensure that they are communicated throughout corporate policies and procedures
Develop strategies, KPI's and written business policies aligned with organizational goals and regulations
This role is based in Zurich, Switzerland and works within a cross-functional, matrixed global organization to drive dynamic performance in all areas
Creates an environment that attracts, develops, and retains high quality employees, foster employee engagement, diversity, professional development and high levels of employee satisfaction

195

Regulatory Affairs Executive Resume Examples & Samples

Bachelor degree in Pharmacy
At least 2-5 years of regulatory experience preferably with a multinational pharmaceutical company in the region
Earlier business background (sales / marketing) will be an asset
Proficiency in local compliance and regulatory, understanding of product life cycle, business awareness, team work and collaboration, project management skills
English and Arabic language skills in written and verbal communication
Based in KSA
Saudi nationality is required for the position

196

Regulatory Affairs & Quality Manager Resume Examples & Samples

Direct supervision of regulatory and quality within the region
Define, implement and execute effective regulatory strategies and processes for Thermo Fisher Scientific ANZ with the goal of exceeding compliance, minimising risk and maximising commercial opportunities
Ensure the appropriate certification and registration compliance of the Company’s medical, scientific and environmental products and services
Assess, co-ordinate, prepare and submit regulatory submissions to meet Thermo Fisher Scientific business objectives across a multi business unit, diverse product portfolio. Provide updates to the senior leadership team and key stake holders across the ANZ organisation
Assess, review, update and proactively manage business priorities and regulatory workflow for Thermo Fisher Scientific ANZ including new product introductions, compliance audits, registration renewals and submissions
Effectively manage communications with all Australian and international regulatory authorities (E.g. TGA) to an appropriate standard, level of priority and timeframe
Provide expert advice across the Thermo Fisher Scientific ANZ organisation, for all matters pertaining to regulatory compliance. Maintain awareness of developments in regulatory, legal, national and international standards that impact or potentially impact the organisation and products
Review and approve product labeling and marketing communications for regulatory and product claim compliance
Ensure accountability/follow through of corrective actions/recalls and communicate with appropriate regulatory agencies
Lead improvement initiatives across the business that will enhance organisational compliance and improve employee awareness around the quality and regulatory function
Proactively partner with key business stakeholders to understand key business matters and any areas of impact from a regulatory and quality perspective
Experience in regulatory affairs with domain expertise in compliance audits, TGA product submissions and renewals
A Bachelor’s Degree (or equivalent) in Scientific discipline
Strong leadership skills with the ability to engage key business stakeholders to achieve required results
Organisational skills with an ability to prioritise time effectively and meet agreed deadlines
Strong communication skills with an ability to develop strong working relations and influence cross functional teams across a complex environment with multiple business units and a broad product range
Effectively communicate across a broad audience including internal and external customers, Regulatory bodies (E.g. TGA), Industry Associations, and internal stakeholders
Exemplary analytical skills with meticulous attention to detail and strong execution
Experience in change management
Self motivated with a drive and sense of urgency to succeed
Understanding of company world-wide regulatory function
Proficiency in routine IT software packages

197

Regulatory Affairs Program Director Resume Examples & Samples

Collaborate across multiple CRHF functions, including Research and Development, Quality, Packaging Engineering, Sourcing, Clinical, Regulatory Affairs, Technical Communications and Operations colleagues in CRHF and Corporate to develop a an EU MDR implementation strategy and execution plan which will achieve full compliance to regulations within the predefined timetable of April 2020
Work within global CRHF organization to form suitable teams to define and execute a prioritized plan while gaining organizational alignment
Responsible for communicating with key stakeholders (e.g., CRHF Sr. Staff, team members), globally and across CRHF, the broader corporation
Prepare regular briefings and participate in the governance/oversight model that ensures confidence in the outcomes of the EU MDR
Provide innovative and strategic guidance for CRHF portfolio rationalization and remediation to achieve EU MDR compliance
Collaborate with and influence CRHF key stakeholders and EU MDR steering Committee composed of CRHF senior staff and functional leaders
10+ years’ experience in the medical device industry in a regulatory, clinical, R&D or quality function
Interpretation of global regulations governing medical devices. In depth project management skills
Proven experience with strategy development, critical thinking and regulation interpretation supporting the commercialization of high-risk permanent implantable devices
Expertise in project management and negotiations with global regulators
Strong organization skills with ability to manage multiple projects simultaneously
Ability to lead by influence across a large matrix organization
Strong analytical abilities coupled with creative problem solving skills
Advanced degree in Engineering, Regulatory Science, Life Sciences or related medical/scientific field, or MBA
Excellent oral and written communication skills; effective interpersonal and influence skills
Comfortable with minimal supervision while maintaining good communication
Ability to travel up to 25% time
History of working collaboratively across functions and geographies
Proven ability to comprehend principles of regulation, quality systems, portfolio rationalization and medical device operations
Expertise in global quality system requirements
Experience working cross-culturally

198

Manager, CMC Regulatory Affairs Resume Examples & Samples

Prepare, author, review, coordinate, manage or maintain simple and complex regulatory submissions, including original INDs, IND amendments, IMPDs, annual reports and agency meeting briefing documents in accordance with applicable regulations
Develop and maintain submission timelines for CMC related issues
Provide thoughtful & accurate comments during document review with focus on US, international, and ICH regulatory guidelines
Review and communicate current and emerging regulatory requirements
The candidate must be able to handle multiple projects simultaneously, while exercising good judgment in prioritizing tasks
The candidate must demonstrate the ability to work independently as well as in matrix team settings
The candidate must have strong oral, written, and interpersonal communication skills.The candidate must also have a high level of attention to detail with proficiency with Microsoft Office applications, Adobe and document management templates

199

Regulatory Affairs Documentation Associate Resume Examples & Samples

Broad global device regulatory knowledge. Expert device labeling requirements and implementation will be an advantage
Ability to perform effectively within complex projects and timelines in a matrix team environment. Strong project management and organizational skills
Ability to identify compliance risks and escalate when necessary
Direct experience with global device labeling will be an advantage

200

Regulatory Affairs Attorney Resume Examples & Samples

Use professional skills and legal expertise to assist in the appeal of Medicare denials
Ensure that appeals meet applicable quality standards
Participate in Hearings before ALJs when required
Research applicable case law and statutory and regulatory guidance related to specific appeals
Perform other special projects not related to a specific case such as general legal research or acting as a liaison for a specific project, when necessary
Demonstrate teamwork and promotes positive company relations
Perform other duties as may be assigned by management
Demonstrated experience in regulatory analysis and/or oral advocacy
Excellent organizational, interpersonal, written, and verbal communication skills necessary
Ability to successfully execute many complex tasks simultaneously

201

Manager of Regulatory Affairs Resume Examples & Samples

Knowledge of scientific and clinical research terminology
Knowledge of FDA and GCP guidelines
Knowledge of organizational policies, procedures, and systems
Skill with MS Office products including Outlook, Word, and Excel
Able to meet strict deadlines
Experience in regulatory affairs
Experience in a supervisory role

202

Senior Analyst Regulatory Affairs Resume Examples & Samples

Knowledge or experiences in establishing and implementing premarket regulatory strategies and post marketing variations
Understanding the US FDA, EU and other country’s regulations in medical device/IVD pre/post marketing registrations, Quality System, GMP compliances, UL and other international standards
Experience in project management tools and applications such as MS word, Excel, PowerPoint, Project, Visio, etc
Excellent proofreading/editing skills and usage of the English language (spelling, grammar and punctuation)
Ability in communicating and working with regulatory agencies, government bodies, and positively interacting with cross-functional colleagues
The ability to work well under pressure and adapt to changing priorities

203

Regulatory Affairs Operations Specialist Resume Examples & Samples

Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives
Responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender support and overall regulatory operations activities
Have a full working knowledge of GTS license types, country regulatory and language requirements
Provide support for Product and Country Experts in the set-up for release of new and modified products globally
Acts as a regulatory representative responsible for review and analysis of GTS blocked orders, providing guidance and direction on regulatory compliance
Reviews and evaluates customer service requests and monitoring of email box for such requests, maintaining a high level of service and follow through on all communications
Ensure communications convey all necessary detail and adhere to applicable regulatory standards
Maintains positive and cooperative communications and collaboration with all levels of employees worldwide; customers, contractors, and vendors
Have a basic understanding of product lines being supported
Have full understanding of Windchill and SAP applications for research, problem solving and analysis of blocked orders and creation of GTS licenses
Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT
Support and submission of CFGs (Certificates to Foreign Governments), CECATS (CDRH Export Certification Application and Tracking System), COEs (Certificates of Export) and Free Sales Certificates (FSCs)
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments
Participates in projects affecting GTS licenses and performs other related duties and responsibilities, as assigned
Ability to collaborate and work cross functionally
Strong organizational and follow-up skills, as well as attention to detail
Strong problem solving skills and ability to think strategically and see the big picture
Adaptable with the ability to switch priorities and accomplish all tasks
Medical device or other medical experience background
Background in Customer Service

204

IT Business Analyst, Regulatory Affairs R&D Resume Examples & Samples

Work with the Regulatory Affairs Business Product Owners to translate business needs for IT solutions and develop/document user stories and/or requirements. This includes data requirements
Develop business cases to secure project funding
Partner with the IT Application Services organization resources to implement the projects following the SDLC Waterfall or Agile methodology for both GxP and Non GxP systems. (Includes project charters, business case, use cases, user stories, data flows, wireframes…etc)
Explain to business partners how requirements may be implemented from a functional standpoint
Coordinate user acceptance testing or assist unit testers so that requirements are satisfied
Partner with SaaS vendors and/or IT Applications Services “Run” organization to establish ongoing Application Support Resources
Partner with other product lines as needed to determine best implementation path of Regulatory Affairs business needs
Responsible for IT Technical Application Ownership (TAO) for assigned Regulatory Affairs systems throughout their Lifecycle and maintain data in the CMDB (Configuration Management Data Base) as needed
Develop deeper knowledge of specific Regulatory Affairs capabilities to help better define appropriate IT solutions. Maps out business processes to serve as reference for development and IT support
Bachelor’s degree in the field of computer science, life sciences or business administration
Minimum of 6 years’ practical work experience as an IT Business Analyst in a life sciences/healthcare organization
Experience developing and maturing processes and systems in a complex regulated environment
Previous experience developing business cases to secure project funding
Previous experience creating project charters, business cases, use cases, user stories, data flows, and wireframes
A strong technical background specifically in software development is required
Quickly learns business and complex processes
Strong communication and critical thinking skills
Ability to work alone with minimal supervision and successfully deliver solutions to our business partners
Previous experience coordinating user acceptance testing or assist unit testers so that requirements are satisfied
Ability to keep the business interests in mind. Strong business acumen
Strong ability to identify technical solutions to business problems or needs
Experience implementing systems using Agile methodology
Experience with software development methodologies
Proven relationship management skills
Ability to partner with different scrum team members to deliver solutions that meet business needs
25% domestic and international travel is requiredBusiness Solutions

205

Director of Regulatory Affairs & Design Assurance Resume Examples & Samples

Partner with Business Unit GM to develop prioritized product pipeline and sustaining project list that support overall business strategy
Develops RA/QA strategy for new products and design changes -- ensuring regulatory requirements for target markets are met
Act as internal regulatory authority for all global regulatory licenses, including 510(k)s, state licenses, regulatory submissions and annual reports
Support regional RA teams to help facilitate licensing, as well as effective post-approval support for complaint handling/reporting, recalls, withdrawals, and notifications
Provide mentoring and guidance to subordinates and other employees
Works within a cross-functional, matrixed global organization to drive dynamic performance in all areas
Comprehensive knowledge and experience with EPA requirements such FIFRA, Pesticide Registration Manual, Health Canada Guidance Document for Disinfectant Drugs, and CFR 40 Parts 150 to 189 2009
Strong working knowledge of EPA Standards: Series 810 - Product Performance Test Guidelines, Series 830-Product Properties Test Guidelines, and Series 870 - Health Effects Test Guidelines
Experience in Medical Devices (HLD/Sterilants), Pharmaceuticals/OTC, Detergents, or liquid/lotion/cream
Working knowledge of global medical device regulatory requirements and product registrations
Comprehensive knowledge and experience with global regulatory requirements and product registrations

206

Manager of Regulatory Affairs Resume Examples & Samples

Develops RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met
Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle
Implements business unit (BU) goals and objectives as related to areas of responsibility, and sets Quality goals and objectives for the Regulatory team
Ensures that resources and activities are aligned with the BU objectives. Effectively communicates progress, problems, and plans
Manages and develops team of Regulatory professionals
Provides appropriate mentoring, appraisals, and discipline of direct reports
Responsible for product registrations, state licenses, and annual reports for Medical Device products globally, through interactions with International Sales Team, in-country business partners and ministries of health
Oversees maintenance of technical files, MDD certifications and declarations of conformity in support of EU product registrations/CE mark
Oversee product recalls/field actions, including regulatory reporting per required timelines
Foster and maintain strong relationships with senior RAQA Regulatory leaders across DHR and leverage best practices and opportunities to drive cross business collaborations and initiatives
Participates in audits and inspections of the company and its quality systems
Works within a cross-functional, matrixed global organization to drive dynamic performance in all areas
Provide strong organizational leadership, ability to organize complex work, drive change and instill a culture of execution, in RA as well as across the broader organization
Attracts, develops, and retains high quality employees, foster employee engagement and professional development
Comprehensive knowledge and experience with global medical device regulatory requirements and product registrations
Possess strong negotiation skills, the ability to interpret and apply regulations, and working knowledge of product development process
Direct experience with preparing and submitting materials for 510(k), MDEL and CE mark

207

Director of Regional Regulatory Affairs Resume Examples & Samples

Ensures that resources and activities are aligned with the commercial objectives. Effectively communicates progress, problems, and plans
Responsible for registrations of new and existing products
Manages and develops team of Regulatory professionals
Provides appropriate mentoring, appraisals, and discipline of direct reports
Manage registration portfolio through daily management and track on-time delivery of registration projects
Collaborating with operating companies on labeling translations
Assessing impact of product design changes on local registrations
Assist in the regulatory review of product labels, literature and websites
Collaborate with operating companies on adverse effects reporting, field corrective actions
Participates in audits and inspections of the company and its quality systems
Direct experience with preparing and submitting materials for local regulatory agencies
Good knowledge of regional governmental policies and culture
Ability to identify, research, and analyze technical documentation and governmental regulations
Strong work ethics, ability to manage change, ability to organize complex work, conduct problem solving

208

Director Regional Regulatory Affairs Resume Examples & Samples

Researching local regulatory framework and providing market regulatory expertise to all the operating companies within dental platform
Collaborate with dealers and local governments on registrations and registration maintenance
Evaluate dealers and other third parties for capability to act on company behalf in local registrations
Provide updates to stakeholders
Create an environment that attracts, develops, and retains high quality employees, foster employee engagement, diversity, professional development and high levels of employee satisfaction
Manage departmental budget
Knowledge of secondary language(s) is a strong plus
Strong management skills, ability to manage resources located in different geographies
Ability to conduct root cause investigation of misses and track progress of countermeasures

209

Manager of Regulatory Affairs Resume Examples & Samples

Strong working knowledge of EPA Standards: Series 810 - Product Performance Test Guidelines, Series 830-Product Properties Test Guidelines, and Series 870 - Health Effects Test Guidelines
Comprehensive knowledge and experience with EPA requirements such FIFRA, Pesticide Registration Manual, Health Canada Guidance Document for Disinfectant Drugs, and CFR 40 Parts 150 to 189 2009
Experience in Medical Devices (HLD/Sterilants), Pharmaceuticals/OTC, Detergents, or liquid/lotion/cream
Working knowledge of global medical device regulatory requirements and product registrations is preferred
Experience with preparing and submitting materials for 510(k), MDEL and CE mark

210

Director of Regulatory Affairs & Design Assurance Business Unit Restoratives Resume Examples & Samples

Participates in the Business Unit Policy Deployment to meet business goals
Responsible for product design quality and reliability to meet or exceed customer expectations and to make quality competitive advantage
Responsible for the implementation of quality targets into products and processes
Foster and maintain strong relationships with senior RAQA Regulatory leaders across DHR and leverage best practices and opportunities to drive cross business collaborations and initiatives
Experience interacting and negotiating with FDA regarding strategy and resolution of complex issues

211

Category Regulatory Affairs Snr Manager Resume Examples & Samples

BSc (or equivalent) degree in a life-science discipline
6-8 years experience within Regulatory Affairs
Knowledge of regulations (Africa, Middle East and Asia) for OTC drug products and Dietary Supplements
Significant experience with a consumer healthcare products
Ability to interpret and understand government regulations
Experience developing strategies to navigate the OTC drug products through the regulatory process in multiple markets, development of compelling claims copy, OTC label review, review of promotional materials
Understanding of clinical process for OTC drugs
Working knowledge of other international regulations (OTC medicinal) governing classification, composition, labelling and claims, and an understanding of the borderline between food and medicinal products
Understanding of Drug Product Listing, Certificates of Pharmaceutical Products and Import/Export regulatory issues
Acts as a Business Partner, making regulatory decisions based on deep understanding of consumer and market insights
Makes decisions based on risk assessments balancing business needs and the needs of consumers, or the risks of being challenged by authorities or competitors
Develops regulatory strategies working within Project Teams in order to secure competitive and compelling claims, a path to market, faster approvals in conjunction with country regulatory teams
Delivery of high quality regulatory files to agreed timelines
Inputs to non-product related activities both within the function in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage
Independently, or in partnership with other critical functions, develop and execute plans to address crises and other sensitive issues that may impact business performance

212

Business Program Lead Regulatory Affairs Systems Resume Examples & Samples

You are responsible to develop an implementation strategy and an implementation plan including capacity planning and controlling of budget, timelines and deliverables
In your new role you coordinate and monitor a set of up to 20 implementation work-streams or projects, including program-level budget planning and reporting. This may include direct project leadership of one or more of these works-streams or projects
One of your key tasks is to ensure the compliance of projects and the delivered solutions with applicable laws and regulations
You will communicate and support the organizational changes that accompany the process and system landscape changes
Your task is to ensure the suitability for the involved business functions of the solution and process architecture being implemented. This includes to drive the realization of benefits
Additionally, you develop, establish, lead and maintain an interdisciplinary program organization to optimally support the program goals and manage program risks
Moreover, you facilitate the organizational alignment with and of the involved business stakeholders and the supporting IT and vendor organizations

213

VP, Testing & Regulatory Affairs Resume Examples & Samples

Excellent leadership and project management skills
Ability to collaborate and network effectively across relevant departments within a global R&D organization
Comprehensive knowledge of business and management principles involved in strategic planning, resource allocation, leadership, and technical and efficiency process methods
Experience working in intercultural and diverse environments
Bachelor’s Degree in Mechanical or Automotive Engineering, or related field, Master’s Degree preferred
10-15 years of relevant experience
Extensive leadership and personnel management experience
Extensive experience in different areas of vehicle development, including vehicle testing activities, durability runs, emission labs, simulation and testing activities, etc
Strong working knowledge of US regulatory agencies including certification topics, testing procedures, safety topics, and the overall rulemaking process

214

Lead-quality Assurance & Regulatory Affairs Resume Examples & Samples

Participating in the development and maintenance of quality systems, processes and procedures to assure product quality and safety
Coaching and mentoring functional teams on the development, maintenance and simplification of local procedures
Assisting the Quality Assurance Site Manager in preparation for internal/external audits and implementation of corrective actions to address non-conformities
Supporting risk management process throughout the product life cycle and providing senior management with key data from RA to help drive decisions
Supporting development and maintenance of product approval/clearance/licensing documentation and notifications as required by global regulatory agencies
Working closely with other functional areas (e.g. Marketing, Engineering, Manufacturing, Service) to ensure compliance to applicable regulations and drive product quality in the areas of Design, Service and Manufacturing
Support the execution of regulatory approvals for products in the applicable target markets
Support new product introductions and installed-base activities so they comply with existing and applicable regulations globally
Timely reporting of adverse events globally
Strong Change Acceleration skills
Front line operational responsibility in Engineering, Manufacturing or Sourcing

215

Regulatory Affairs, Senior Manager Resume Examples & Samples

Preparation and timely completion of FDA submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs (Pre-Submission, 510(k), de Novo, PMA supplement, PMA annual report, etc.)
Participation on cross functional project teams to provide strategic and tactical guidance to meet US FDA requirements,
Development of regulatory plan for US submission and/or global regulatory plan for US manufactured IVD products
Assessment and applicable documentation of changes in product, manufacturing processes, labeling affecting IVD products distributed in the US, including communication to global Regulatory and project teams for impact assessment
Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of US manufactured IVD products
Maintain up-to-date knowledge of US IVD regulations and applicable guidances, monitor development of regulations and communicate impact to the business
Provide input and feedback on clinical study protocols to ensure US regulatory requirements are incorporated
Act as FDA liaison for US submissions and other interactions regarding regulatory matters, including preparing for and attending meetings with the FDA as required
Support CE marking activities for US manufactured IVD products
Review and approve promotionalmaterials and product labeling
Prepare USDA importation / exportation permits
Prepare export notification to FDA
Manage the day-to-day activities of the Regulatory Product Release system (product classification, set up of licences, release of orders, etc.)
Bachelors Degree in life science related field (Medical Technology, Clinical Chemistry, Biology)
Minimum of 5 years of experience in managing all aspects of preparing and filing FDA submissions for IVD and/or medical devices and overall 10 year direct industry experience
Excellent understanding of FDA regulations and guidance documents required
Previous experience supporting international registrations (FDA, CE) required
Limited travel (up to 10-15% of the time, or as circumstances dictate)
Excellent interpersonal, verbal and written communication skills (in English)
Excellent time management, organizational, negotiation, and problem solving kills
Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management

216

Regulatory Affairs / QA Manager Resume Examples & Samples

Regulatory –
5-8 years relevant experience working in a medical device company
3+ years of experience in serving as Technical Responsible Person or experience in Quality/Regulatory for medical device/IVD/Pharmaceuticals company
Experience with both capital equipment and disposable devices

217

Manager of Regulatory Affairs Resume Examples & Samples

Minimum six years medical device regulatory experience
Extensive experience with US and global medical device regulations and submissions
Ability to travel approximately 15%, including internationally
Experience with Regulatory capital equipment and disposables, 510 filing and EU and Canadian submissions for product approval/clearance, tech files desired

218

Regulatory Affairs Administrator Resume Examples & Samples

Maintain and update the departmental scanned filing system, ensure that documentation is easily accessible
Give assistance to the Regulatory Affairs team in order to maintain and update the departmental database(s)
Act on behalf of the Regulatory Affairs team in order to respond to straightforward correspondence (both internal and external)
Preparing and submitting regulatory information for the Internet and Intranet
Provide support with proof reading new or substantially changed packaging items
Responsible for photocopying and binding Regulatory Affairs data packages which need to be sent externally
Assist in finding product information from Regulatory Affairs databases in response to requests from Intervet International
Achieve the required objectives as quickly and efficiently as possible in order to ensure a good performance of the departments concerned
Increase knowledge of the regulatory affairs, pharmacovigilance and marketing

219

Regulatory Affairs Executive Resume Examples & Samples

Doctor of Pharmacy
Basic English skills
Sound understanding of basic Regulatory guidelines both locally and internationally
Enthusiasm of entrepreneurs
Improved and well channelled lobby strategy
Contributing with Passion and an unmatched sense of urgency
Review registration dossier versus regulatory requirements and ensure its completeness
Prepare and compile registration package for Established Products, New Chemical Entities, Line Extension etc…
Dispatch dossier to local contacts and ensure timely submission to Regulatory Authorities (RA)
Support in managing regulatory questions and ensure that responses are submitted in time
Regular follow up with RA and local contact to secure regulatory approval and speed time to market
Maintain Local and Global Databases (OPAL, Regulatory trackers...)
Initiate Product Sourcing Request (PSR) when required
Support in the pack management process for creation, review and approval artwork changes and new pack request
Support other regulatory activities to achieve overall objectives when required

220

Compliance, Regulatory Affairs, VP, Frankfurt Resume Examples & Samples

Assess the firm’s compliance, regulatory and reputational risks
Monitor for compliance with new or amended laws, rules and regulations
Design and implement controls, policies, procedures and training
Conduct independent testing
Investigate, monitor for compliance risks and breaches
Lead the firm’s responses to regulatory examinations, audits and inquiries
Minimum of five years’ experience in compliance related role within a financial services-related environment
Detailed understanding and experience of EMEA banking and other financial services
Experience in dealing with complex issues and the ability to initiate and co-ordinate projects on a cross-border basis
Experience with the MaComp and MaRisk regulatory framework
Experience in areas of market infrastructure, exchange regulations and capital markets
Relationships – successfully building impactful relationships within and outside complex organisations
Execution excellence – thorough and diligent with strong attention to detail. Meets deadlines. Follows up issues
Ask Questions – speaks up and asks probing questions
Creativity – looking for solutions to issues and problems; and
Holds oneself accountable and is able to step up to challenges which you may not have previously encountered
Language skills advantageous

221

Regulatory Affairs Technologist Resume Examples & Samples

Review and update all existing raw material questionnaires and ensure complete and accurate data is entered and rolled up in Optiva
Development of Label Compliance Specifications for updated Country of Origin Artwork
Manage external supplier contacts and RA timelines to achieve delivery of Country of Origin labelling to June 2018 deadline
Process development and training to ensure ongoing process compliance. Ensuring rapid response in changes from procurement to labelling and production

222

Mgr, Regulatory Affairs Advertising Promotion Resume Examples & Samples

Responsible for providing operational leadership and sound regulatory advice consistent with applicable FDA regulations and guidance documents, FTC regulations, PhRMA guidelines, and company policy while meeting business needs for assigned products at every stage of the development of promotion programs/materials. Has approval authority on all promotional items under limited direction of the Director/Exec. Director
Works collaboratively with the business to ensure that promotional practices are consistent with regulatory guidelines and support business objectives. Proposes creative solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk
Under limited guidance of Director/Exec. Director supports US brand teams, Public Affairs Department and others by participating in strategy discussions and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. Provide regulatory input on concepts and draft promotional materials to help assure promotional materials satisfy U.S. promotional regulations, corporate standards and policies and business objectives
Manages activities related to promotional materials submission to OPDP at the time of the initial dissemination. Management of all Advertising and Promotional projects through the Electronic Approval System
Identify continuous improvement opportunities, initiate improvements in department processes, develops staff to assume greater or more diverse responsibilities, provides performance reviews to direct reports and ensures department meets corporate objectives in the performance evaluation process. Manages the process of updating and maintaining appropriate standard operating procedures for the department. Trains new hires and other Specialists and Associates
Identifies and provides suggestions and manages the process for improvements/corrections within the Advertising and Promotional Compliance department. Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders
Maintains a productive relationship with FDA to help ensure successful and timely review of advisory submissions and effective resolution of regulatory actions
Under limited guidance of the Director/Exec. Director develop and implement effective strategies for FDA submissions for advisory. Manage the development of correspondence with FDA and the interpretation of FDA advisory comments for assigned products

223

Intern, Regulatory Affairs Biologics Resume Examples & Samples

Support initiatives including, execution of regulatory strategies for Biosimilars as a key growth driver
Track status of deliverables necessary to support upcoming Health Authority submissions
Assist with authoring, editing and formatting of regulatory correspondence, relevant submission sections and associated reports
Compile submissions in eCTD format within DCM
Track status of projects and prepare/update status reports
The successful candidate will have preferably completed a minimum of their sophomore year and be currently enrolled in an accredited college or university in a Biological Science, Chemistry, Biochemistry degree program, or a related field of study. A minimum 3.0 GPA is strongly preferred, however, a combination of experience and/or education will be taken into consideration
Must possess knowledge of chemistry, biology, and the sciences
Must possess excellent communication skills (both oral and written), technical background, strong organizational skills, good interpersonal skills, accuracy and attention to detail with a strong work ethic. Computer skills should include Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Proficiency in speaking, comprehending, reading and writing English is preferred

224

Field VP Regulatory Affairs Resume Examples & Samples

At least 7 years’ experience in working in a management position either in, or with, regulatory agencies
At least 2 years’ experience in the dialysis industry
Staff and project management experience
Proven project and staff leadership/management skills including, but not limited to: management of crisis or unforeseen issues, communication, customer service, performance management and continuous quality improvement
Strong personal computer skills

225

Head of Quality Management & Regulatory Affairs Resume Examples & Samples

Development & maintenance of Quality Management System (QMS) of the certified legal entities
Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits
Introduce new systems and procedures where appropriate
Responsible for Safety Swiss EKAS implementation within QMS
Internal QMS audits according the annual audit program
CAPA Governance and Monitoring
Manage Regulatory Affairs (RA) including external product registrations to ensure they comply to applicable standards in the market
Member of Project steering committee and Safety board
Responsible for dangerous goods and known consignor obligations
Major QM-Standards: ISO 13485 (EU), JPAL Ord 169 (Japan), 21 CFR 820 (USA)
Main Regulatory Standards: Medical Device Directive 93/42/EEC, R&TTE Directive 99/5/EC, 21 CFR 821 (USA), EN 60601-1-2

226

VP, Regulatory Affairs Resume Examples & Samples

Monitoring, notification, and guidance to business lines on industry news and proposed or regulatory changes, including quarterly reporting to senior management
Oversight of regulatory inquiries, including monitoring, notification, tracking, and reporting
Serves as the primary contact for regulatory agencies, including corresponding and interacting with regulators on relevant issues
Representation of the firm at various regulatory agency meetings and events
Ensures timely and accurate reporting of required regulatory filings
Liaison with counsel and other stakeholders on regulatory matters to limit legal exposure such as enforcement sweeps
Gathers applicable documents and draft responses to routine regulatory inquiries and examinations. Tracks and pulls requested documents and coordinates efforts with departments/branch offices to gather information. Researches and drafts responses where necessary. Reviews information for trouble spotting prior to submission to regulatory agency
Advises on the development of new or revised policies and procedures for the firm by attending applicable meetings, giving input, performing research, producing written drafts, making changes and assisting with implementation and training, where applicable
Performs reviews as necessary to ensure compliance with regulations
Corresponds and interacts with other members of Compliance, home office and branch associates, including Financial Advisors, Branch Managers, and support staff on relevant issues
Corresponds and interacts with various business units throughout the Firm and its affiliates as needed to assist in development and implementation of policy and procedure changes resulting from regulatory reviews or examinations findings
Performs human resources activities, including administering progressive discipline policies; evaluating performance; approving recruitment of new or replacement positions and approving training and development recommendations and providing appropriate developmental resources
Performs other duties as assigned by Chief Compliance Officer
Concepts, practices and procedures of securities industry compliance
Rules and regulations of the Securities Exchange Commission (SEC); Financial Industry Regulatory Authority (FINRA); and state securities regulatory agencies
Financial markets and products
Investment concepts, practices and procedures used in the securities industry
Investigating compliances issues and irregularities
Making rule-based and analytical decisions
Identifying and applying appropriate compliance monitoring procedures and tests
Written and verbal communications skills sufficient to professionally address a wide and varied audience both internally and externally
Preparing oral and/or written reports
Operating standard office equipment and using required software applications
Work under pressure on multiple tasks concurrently, manage those delegated; and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities
Attend to detail while maintaining a big picture orientation
Use appropriate interpersonal styles and communicate effectively and professionally, both orally and in writing, with all organizational levels to accomplish objectives
Establish and communicate clear directions and priorities
Maintain currency in laws, rules and regulations related to compliance in assigned functional area (s)
Plan, assign, monitor, review, evaluate and lead the work of others; coach and mentor others
Manage all levels of associates, including technical, professional, clerical, administrative and supervisory associates
Work independently as well as collaboratively within a team environment to resolve problem
Bachelor's Degree (B.A.) in a related discipline required, J.D. preferred
General knowledge of securities and related business with ten (10) + years of financial services-related experience and five (5) years management experience within the financial services industry

227

Scientist, Regulatory Affairs Resume Examples & Samples

Products Labeling Reports (PLRs) generation for local brands for the country of scope
Regulatory key contact in Local project team
LABEL spec generation, PROD spec review including H&W policies
Handling general enquiries from local authorities
PLR translation review and local approval for MEU brands sold in Czech Republic
Labeling coordinator role for a MEU brand
Regulatory key contact in the MEU project team
LABEL spec generation, PROD spec review including H&W policies, Master Artwork Review
Pre-review of claims, advertisements, media
Preparation of regulatory assessments
Providing regulatory guidance to RD&Q, PCMs, Marketing, Consumer services
Providing technical information on products to answer enquiries from local Authorities
Variations pre-review (preparation of the consolidated regulatory assessment) in collaboration with local experts when needed
University degree in Food Technology (or related degree)
Organizational agility
Priority Setting
Ability to work in English
Fluency in Czech language

228

Regulatory Affairs Supervisor Resume Examples & Samples

Prepare and follow through the complete process of product registration with the SFDA and other Chinese Government departments
Set up company RAQA procedures
Work with the sales/marketing team to plan and prioritize the product registrations and to assist in resolving any issues and problems that may arise in the field
Help company develop close relationships with Government Departments and Officials to facilitate the implementation of product registration strategies
Handle post market quality issues like product complaints, Adverse event reporting and recall
Update quality files like Chinese labels and Manuals database to be compliance with SFDA regulations
Give medical device regulatory trainings to Sales / Marketing/ Dealers
Work with Legal to assist business licesne update
Lead the application of distribution license if necessary
Lead and pass local FDA audit

229

Quality Assurance & Regulatory Affairs Leadership Program Resume Examples & Samples

Successful completion of three rotations
Successful completion of all current graduation requirements, including coursework in areas such as: Presentation Skills, Foundations of Leadership, LEAN and Change Acceleration Process (CAP)
Participation in 1 Global Quality Compliance Audit
End of rotation presentations to the GEHC Quality staff
Relevant internship/co-op/work experience
Academic excellence, business acumen, leadership ability
Global mindset; ability to operate across cultures

230

Lead-regulatory Affairs Intel & Analysis Resume Examples & Samples

Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop and implement company-wide intelligence programs and processes for regulatory affairs compliance within areas of responsibility
Expand current competitive intelligence gathering processes, design and implement special competitive intelligence projects
Provide focused, actionable analysis and well-written communications of collected findings. Design and build analytical tools to drive fast and efficient intelligence dissemination
Analyze data in spreadsheets and databases to identify regulatory trends and their implications for GE Healthcare; Monitor and research key sources of information and input findings into database
Analyze and communicate proposed, new or changing requirements, and devise strategies for their implementation, ensuring business goals are met
Educate, train, and advise company professionals on Intelligence findings and analytical tools/concepts
Expand the existing source networks for competitive intelligence and track internal and external trends that could lead to impact on GEHC business
Collect, summarize and evaluate performance metrics and align information collection priorities with business strategies
Stay current on competitive intelligence innovations and new intelligence, analytical and information management tools
Assist in the design and build of intelligence databases
Support continuous improvement activities with regard to areas of responsibility
Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
Effectively support implementation & management of current regulatory requirements within area of responsibility
Bachelor’s Degree & minimum of 4 years progressive experience in analysis in one of the following fields: Business Intelligence; Military Intelligence; Financial Analysis; Regulatory Intelligence; Legal; Quality Management
Strong project management skills, ensuring high quality deliverables to established strategic goals
Competent in using Microsoft Excel for organizing data, building charts, and conducting analysis
Demonstrated knowledge & experience in researching and collecting data conducting in the one of the following disciplines: regulatory, financial, military, scientific, legal, or business
Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
Prior experience using analytical tools/platforms, database applications and presentation software
Ability to work well independently & in a team setting
Strong problem solving and influencing skills
Ability to work with ambiguity and undeveloped/abstract concepts
Must be willing to travel up to 10% of time

231

Manager Commercial Regulatory Affairs Resume Examples & Samples

Provide regulatory advice and risk assessment on concepts and final advertising/promotional materials, sales training materials, and external communications for marketed products, as assigned
Assure full regulatory compliance of all promotions with approved labeling and FDA guidance
Build a strong relationship with internal customers; including Commercial, Legal and Medical
Begin to develop relationships with OPDP
Prepare communications with guidance for OPDP concerning sub part e and advisory submissions
Participate in review of product labeling submissions
Works with management to ensure that changes in US PI are reflected in current promotions and advertising
Bachelors Life Science degree required; advanced degree preferred (MS, PhD, PharmD, or JD)
Candidate should have a minimum of 1-2 years Regulatory promotional review experience
Candidate should have experience providing strategic direction to interdisciplinary teams on promotional materials activities for marketed products and strong interest in FDA advertising and promotional practice regulations including guidance(s)
Broad “hands on” related pharmaceutical experience (prefer 5 years pharmaceutical industry experience) and actual FDA regulatory experience
Detail & deadline oriented; well organized
Good interpersonal skills; ability to interact with staff on all levels

232

Regulatory Affairs Consultant Resume Examples & Samples

Ensure compliance of the registration of Bayer Environmental Science Turf & Ornamentals Insecticides and Ornamentals products and Specialty Actives products with the Environmental Protection Agency regulations and agreement with strategic business objectives
Summarize data across study types and prepare core dossiers and technical positions for regulatory submissions as required
Maintain registrations through timely compliance with all regulatory requirements
Compile additional regulatory studies according to specific needs of the respective countries / regions
Work with relevant Bayer CropScience functions to ensure necessary studies to secure the registration of new registration projects and defense of our existing products, projects, or third-parties products in timely fashion
Elaborate and discuss comparison between Bayer and the main competitor compounds
Bachelor's degree in health, physical or natural sciences or other relevant discipline with eight (8) years of relevant experience; or
Master’s degree in health, physical or natural sciences or other relevant discipline with six (6) years of relevant experience; or
Ph.D. in health, physical or natural sciences or other relevant discipline with four (4) years of relevant experience
Ability to anticipate future developments and/or changes and develop appropriate regulatory strategies for assigned products
Ability to effectively communicate critical information that relates to assigned products to Environmental Science business unit, appropriate Bayer technical experts and others to resolve and/or reduce potential regulatory impacts or costs
Proven experience and proficiency to influence or persuade internal and external customers and stakeholders
Ability to know when to stay the course or revise strategies or approaches to achieve the best possible outcomes
Strongly demonstrated problem solving skills
Strongly developed verbal and written communication skills and ability to communicate with all levels both within the organization and externally
Ability to work in ambiguity
Ability to establish trust and confidence quickly
Experience working with state and/or federal government agencies
Broad knowledge of EPA pesticide regulations and requirements for submission of registration applications

233

Product Regulatory Affairs Intern Resume Examples & Samples

Pursuing a Bachelor's degree or Master's degree in engineering, environmental science or have a concentration in related curricula associated with environmental work, with a GPA of 3.0 or higher
The desire to learn about the U.S. Federal and international automotive environmental regulations
Strong technical writing skills, interpersonal abilities, a cooperative attitude, adaptability and cultural sensitivity
Proficiency with Microsoft Office - particularly Excel, Word and PowerPoint
Monitoring, identifying and reporting on federal and state activity with a focus on criteria pollutant, greenhouse gas and CAFE regulations
Evaluating and reporting on interaction between international environmental automotive regulations and associated compliance or monitoring groups
Conduct research for the purpose of circulating Advance Briefings on a number of Toyota's technical focus areas
Support team efforts to interact with federal and state agencies with possible additional focus areas on the energy sector, fuels, and transportation economics
Other projects and tasks, as needed, including editing a monthly update publication; ensuring that team reports are accurate and circulated in the U.S. and Japan; participate in team calls and meetings; meet and learn about how TMNA's different groups interact and work cooperatively

234

Expert Product Safety & Regulatory Affairs Resume Examples & Samples

Assessment of toxicological studies, literature data, and health and safety data to create a safety assessment andhazard evaluations for substances and/or products
QA and Authoring of SDSs and Labels
Maintaining a strong understanding of global hazard communication regulatory requirements
Required Education:Master/PhD in Chemistry, Chemical engineering, Biology or related EHS directly reacted field
SAP EH&S experience would be an advantage
More than 3 experience as Product Safety and Regulatory Affairs Expert
Provide expertise on European regulations related to hazard assessment of products with particular emphasis on safety data sheet legislation (CLP/GHS, ADR, etc… )
Ability to compile SDSs (acc. REACH Annex II). Official examination a plus
Ability to multitask and prioritize work

235

Senior Manager Quality & Regulatory Affairs Resume Examples & Samples

Scientific/Biochemistry background: Master of science
Successful experience in leading a QRA team in Medical device/IVD industry – 10 years +
Excellent communication skills – ability to build trust and engagement across cultures
Ability to work cross culturally/functionally and understand functional department requirements
Excellent organizational capabilities
Highly ethical, is able to multi-task and prioritize in a competitive environment

236

Regulatory Affairs Consultant Resume Examples & Samples

Facilitate favorable regulatory outcomes through establishing appropriate internal and external meetings, advising on appropriate data generation, and negotiation of requirements, labeling, and risk mitigation
Plan, coordinate, and prepare registration applications, scientific documents and information for new products, additional crops, new or revised use patterns, data call-ins, special reviews, and petitions for tolerances
Interact with regulatory agencies to obtain timely approval of pending petitions, applications and actions
Maintain knowledge of current pesticide regulations and contact with key regulatory authorities. Convey critical knowledge, especially that relating to assigned products, to BayerCrop Science management, appropriate BCS Science scientists, and others to alleviate or reduce regulatory impacts and costs
Ensure compliance with all applicable requirements, including but not limited to ensuring that product-labeling claims are correct and current
Coordinate regulatory activities with North American counterparts, global counterparts, and other business units to optimize regulatory approaches and approvals. Represent BCS in industry trade association or work group activities as needed
Bachelor's degree with six (6) years’ of minimum relevant experience Master’s degree with (4) four years’ of relevant minimum experience Ph.D. with (2) two years’ of relevant minimum experience
Knowledge of EPA pesticide regulations and submission requirements, specifically 40 CFR part 158
Developed written and oral communication skills
Ability to construct persuasive scientific documents to support/ defend registrations. Proficiency and experience in negotiation and influencing others to change their thinking
Experience in summarizing data across study types and preparing technical positions for regulatory required submissions. Scientific knowledge of applicable area(s) to the regulatory process
Ability to work well with others and in a team environment
Basic understanding of forecasting and budgeting
Coordinate development of annual registration team budgets, and interact with Regulatory Intelligence and Regulatory Support teams to identify Federal Registration needs
Knowledge of data structure and data management with experience in compiling and managing data bases

237

Manager of Regulatory Affairs Resume Examples & Samples

Coverage of PJM wholesale markets on behalf of Demand Response business interests of EnerNOC including coverage of and advocacy in wholesale market matters via the PJM stakeholder process, FERC and other related and appropriate venues
Coverage of State Regulatory matters impacting ENOC demand response and procurement businesses at the retail level and at the wholesale level
Advocacy for State programs aligned with our business model as well as lobbying for State support of our wholesale energy market interests
Employee will be responsible for internal coordination of regulatory matters with relevant business units, including ensuring awareness of important matters, developing and advocating positions on behalf of our business interests, and providing other needed support for regulatory matters impacting our book of business
Leverage ability to write, edit, research, review filings and briefings will be necessary as you will deliver effective messages to key legislative and regulatory staff
Leverage both written and verbal presentation skills to represent EnerNOC and its positions on market matters in both informal venues and formal docketed proceedings
Actively work inside RTO/ISO stakeholder processes and other appropriate regulatory and legislative and regulatory arenas to advocate for rule development for the EnerNOC markets and its commercial end-users
Market and or regulatory experience preferred
Location – local to PJM facilities or in Boston office dependent on candidate’s qualifications
Bachelor’s degree in a related field, Advanced degree preferred

238

Regulatory Affairs Junior Manager Resume Examples & Samples

Regulatory advice and support to Brand Team on promotional materials content
Review and approve promotional materials
Keep updated in current regulations in promotion of medicines and in Spanish Code of Practice for the Pharmaceutical Industry
Participation in Brand teams and internal discussions regarding regulatory strategies and proposed label changes, to provide regulatory advice for new and existing products
Provide regulatory support for the commercial divisions in all areas pertaining to product life-cycle management and new product development
Plan and achieve regulatory actions for new products/Indications launches
Review and ensure proper regulatory submission to the Health Authorities
Ensure tracking and communication to Regulatory Area
Liaise with external authorities/ organizations as required
Liaise with European Regulatory and Corporate groups
Ensure compliance with all relevant statutory requirements and all relevant internal procedures
Keep track of regulatory new guidelines
Review and approve local regulatory procedures in line with global procedures
Represent affiliate regulatory position at defined initiatives or projects from global or area
Ensure training to other affiliate personnel regarding relevant Regulatory Affairs related local procedures
Life sciences degree (e.g. Pharmacy)
Extended experience in Regulatory Affairs
Experienced in promotional activities and materials review

239

Manager, Government & Regulatory Affairs Resume Examples & Samples

Identifies important municipal issues of significance to the company
Reviews, interprets, and communicates meanings of the terms and conditions of franchises, franchise-related agreements, and other contracts for implementation to ensure compliance with legal and regulatory standards
Position location may be flexible in the Greater Seattle Area
Must have experience in successfully lobbying/advocating before elected officials and public bodies
A network of political relationships and understanding of government relations strategies and political landscape in Washington State is desired
Superior communication skills, oral and written, with continuous attention to detail in legal, business and opinion/persuasion communications
Experience in working with the law telecommunications a plus
Strategic thinker, with experience with contract law and negotiations
Ability to articulate technical concepts in an understandable way to a non-technical audience
Good decision-making skills, tactful, excellent listener, willingness to seek answers, and an ability to recognize when others need to be involved in activities or decisions
Strong organizational, project management and planning skills required

240

Principal Specialist, Regulatory Affairs Resume Examples & Samples

Participate as a core team member on new product development teams providing regulatory guidance
Provide regulatory guidance for changes to existing products
Develop regulatory strategies for new and modified products
Preparing regulatory filings such as pre-IDEs, premarket notifications, technical files, Canadian submissions and letters to file
Perform regulatory research
Review and approve promotional materials
Support Health Hazard Assessments and Field Actions
Support international registrations
Mentor regulatory specialists
Project management for designated regulatory initiatives
Bachelor’s degree required preferably in science or engineering (MS or PhD degree preferred)
6 years regulatory affairs experience in Medical Device environment, or equivalent (IVD experience preferred)
Knowledge of 21 CFR 820 and ISO 13485
Knowledge of the US and European IVD regulations
Team player demonstrating good organizational and communication skills
Self-starting demonstrating initiative
Technical writing skills

241

Regulatory Affairs & Reimbursement Manager Resume Examples & Samples

Providing constant inputs from a Regulatory perspective within the review process of promotional materials/activities, to ensure compliance with company/sector/law requirements
Ensuring compliance with all regulatory requirements (e.g. timely submission of dossiers, proper implementation of new national and international legislation, training on SOP’s & supporting system, etc.)
Keeping him/herself up - to - date about regulatory guidelines/directives/national requirements in order to provide appropriate advice and organize internal training programs
Strong expertise in Regulatory Affairs and Reimbursement process

242

Regulatory Affairs Senior Specialist Resume Examples & Samples

Coordinate and ensure registration pipeline/changes and renewals program submission is done in timely manner
Participate in teams to establish and execute regulatory strategic plans with minimal guidance
Prepare and submit proper regulatory documents and technical files to MoH with minimal supervision
Provide assistance with establishment registration licenses
Contribute to introduce new /modified products/ extension line & others
Manage and track regulatory projects/requests to ensure alignment with business goals and timely responses
Prepare alert communications according to registration process progress and findings during this
Coordinate information on several projects simultaneously
Supports regional team on product submissions schedules, prioritization and pipeline management
Interacts with other JJ personnel, government agencies in a professional, decisive, & articulate manner
Act as liaison for assigned franchises to support business plans and regulatory needs
Request and follow-up documentation from OCs to prepare registration dossiers
Review and analyze market licenses and labeling to set up product codes status
Ensure that Registered Codes Database, Labeling Database and Scanned Registers are well updated as per approvals received
May identify and communicate new regulatory/legal requirements
Support franchise, bids and functional areas consultations to clarify regulatory questions/ conditions
Actively participation and timely delivery results in RA teams to achieve common goals or attend common strategies
Adhere to -company and regulatory bodies’ policies and procedures regarding product introductions, changes and labeling
Support to review promotional materials according to current product registration and MOH regulation
Must have 3-4 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for complex devices and a successful track record. Desirable experience in Medical Devices, Pharma background is acceptable

243

Supervisor, Regulatory Affairs Resume Examples & Samples

Drive Regulatory Affairs function, by managing processes and reporters
Subject matter expert on various regulations as well as coordinate issue resolution through the use of outside consultants, regulatory agencies, and / or internal resources
Organizes work on the registration of all company products in Roszdravnadzor
Organizes work to obtain the required permit documentation in the certification bodies
Prepare product regulatory submissions and assist in activities to support the approved products during their lifecycle
Arrange to obtain necessary for the registration of documents from the manufacturer
Organizes the required trials.Controls and monitors process of registration and certification processes
Participate in Project Teams and New Product Introduction Teams to support product launch
Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc
Prepare regulatory submissions for authorities in other countries as required

244

Head of Quality Assurance & Regulatory Affairs Resume Examples & Samples

Create and implement all quality procedures
Manage and establish/maintain compliance with FDA QSRs (GMP) including company registration, new product submissions, establishing FDA communication/channels for compliance on medical device listings/classifications, management of CAPA system
Manage and establish/maintain compliance with the EU market MDD 93/42/EEC directive and the Canadian MDR (including CE Mark applications or self-declarations via technical files)
Manage and establish/maintain certification of ISO 13485 requirements
Responsible for the customer complaint system and generating the monthly customer complaint report
Responsible for evaluating product failures and generating the evaluation report
Responsible for working with R&D and manufacturing to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing
Conduct internal audits and coordinate and manage external ISO audit schedules, correspondence and closing of findings
Ensure compliance of labeling and advertising
Audit Design history files for new products for FDA compliance, if needed
Manage sterilization records and facilitation with contract sterilizer and 3rd party validation processes
Responsible for quality control and a quality system for SMP’s products and products that we are the legal manufacturer
Responsible for reviewing and establishing the company quality goals each year
Establish an export compliance system
Responsible for meeting regulatory requirements in foreign countries for registration of medical products
Responsible for the Documentation Control Process and Documentation Change Control
Bachelor of Science degree required
Medical device experience required
Experience in cGMP and other Regulatory compliance requirements
Experienced in regulatory filings for US (510(k), IDE and PMA) and other key countries/regions
Some international travel required
Considerable experience in Quality Assurance and Regulatory Affairs (Seven + years)
Medical imaging quality and regulatory experience preferred
Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization strongly preferred

245

AVP Government & Regulatory Affairs Resume Examples & Samples

Lead the development and implementation of a strategic and proactive government affairs plan by
Establishing "advocacy" committees on topics that cross the Business Units (BU)
Connecting with the risk management and business planning processes of the Canadian BU on major public policy risks such as health care, the bank act review, transparency in fees, genetic testing, and others
Updating executive teams regularly in a structured way on advocacy priorities and emerging issues
Managing representation on Canadian Life and Health Insurance Association (CLHIA) committees, Canadian Chamber of Commerce, IFIC, Business Council of Canada, etc
Lead the creation of a Canadian regulatory affairs function including
Preparing submissions to regulatory authorities
Tracking emerging changes to regulations
Building relationships with regulators as required and managing our proactive outreach with regulators and their key influencers
Draft key messages, speeches and background briefs for use by senior Sun Life Financial representatives (CEO and Business Unit President’s)
Represent Sun Life at meetings and stakeholder consultation sessions with Canadian Government, think tanks
Specialized knowledge of public policy issues pertaining to the Canadian business sector generally and financial services specifically, to wealth management, pensions and health care
Specialized knowledge of workings of provincial and federal governments and the public policy process
Knowledge of the Canadian financial regulation landscape and key players - wealth management, pensions, benefits, insurance
Demonstrated leadership skills in working independently and performing highly complex assignments, developing, coordinating and executing strategies
Excellent speech / presentation writing ability
Strong research and analytical skills, and in-depth knowledge of the business group strategy and objectives
Minimum 10 years’ experience (or equivalent) in public and government affairs
Experience in the financial services sector an asset, including insurance, banking, wealth management, pensions
Undergraduate degree plus Masters degree or Law degree is an asset
Bilingual an asset
LI-JW1

246

Senior Executive Regulatory Affairs Resume Examples & Samples

Graduate/ Post Graduate in Lifescience/ Bio Medical/ Pharmacy
Sound understanding of MD&D rules and regulations
Experience in quality/ manufacturing and regulatory affairs in medical devices would be advantage
Good technical writing and communication skills.1700164275W

247

Regulatory Affairs Scientist Resume Examples & Samples

Provide regulatory support throughout registration process
Provide regulatory support throughout life-cycle management
Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
Assist with submission and acceptance of MAA
Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
Review protocols and ensure alignment with regulatory requirements
Advise team on required documents and submission strategies in preparation of CTAs
Ensure CTA submission packages are complete and available according to agreed timelines
Oral & written communication skills
Organization & multi-tasking skills
Knowledge of the regulatory environment, guidelines and practice of EMEA regions

248

Regulatory Affairs Administrator Resume Examples & Samples

Matric Certificate
Minimum 2 years experience in Regulatory Affairs as an assistant within the Pharmaceutical Industry
Basic Scientific and medical knowledge
Knowledge and experience of Regulatory Affairs and CTD dossier format
Ability to prioritise and work on tight deadlines
Detail orientated and organised
Advanced typing skills
Analytical and interpretative skills
Excellent computer knowledge – proficient in MS Word, Excel
All administrative functions for the Regulatory Affairs department
Management of all filing, copying and preparation of new product submissions and variations under the direct supervision of the Regulatory Affairs Manager
Filing of all MoH correspondence received from MoH and submitted to MoH
Setting up of SSA meetings for the team, ensure minutes and agenda are sent out prior to meeting and ensure minutes are captured and agreed prior to dissemination to team
Complete responsibility for Product Dossier Management both hard copies and soft copies (RA Manager is accountable)
Management of Product Information Files and Medical Device Technical Files
Payments of applicable fees to MoH, other regulatory bodies and associations
Management of OPAL events, variations and approvals for SSA

249

Head Oncology Regulatory Affairs Companion Diagnostic Resume Examples & Samples

Maintain oversight of regulatory strategies for all projects with an In Vitro Diagnostic Device (IVD) / Companion Diagnostics (CDx) component
Develop and maintain the IVD/CDx strategy template
Advise on IVD/CDx strategies that are aligned with oncology drug development
Coordinate regulatory consultancy input into IVD/CDx regulatory strategies
Provide IVD/CDx regulatory input to multiple development projects
Advise Global Regulatory Strategists (GRSs) on individual IVD/CDx regulatory strategies as part of the broader project regulatory strategy
Contribute to CDx Target Product Profile (TPP) development
Provide IVD/CDx regulatory advice to Early Development Project Leaders / Biomarker Project Leaders / Early Clinical Leaders and the respective late development roles
Provide specialist IVD/CDx input and reports to early and late GPTs
Prepare and lead dialogue with Health Authority (HA) representatives to support the acceptance of the IVD/CDx strategy
Manage multiple IVD/CDx development partnerships
Provide regulatory feedback on partnership contracts
Build and maintain relationships with regulatory colleagues from the CDx partner companies
Substitute for Regulatory representative on Joint Collaboration Committees as needed
Participate in project review meetings
Propose ideas to facilitate improved collaboration
Coordinate and prepare IVD/CDx regulatory documentation
Send Submissions to Health Authorities or Ethics Committees
Answers to HA and European Council (EC) questions related to diagnostic testing
Ensure partner IVD/CDx labeling and Instructions for Use is consistent with Bayer target labelling
Contribute to internal regulatory IVD/CDx expertise development
Establish and coordinate knowledge sharing platform within Regulatory Oncology and cross-functionally within Oncology Strategic Business Unit (SBU)
Establish IVD/CDx Regulatory Community Group, contribute to Biomarkers Community group
Develop and share Bayer Oncology Case Studies
Design, prepare and implement training programs
Monitor key changes in the global regulatory environment in the area of personalized medicine, with special focus on diagnostic tests
Build the internal and external network and represent Bayer in relevant industry associations
Monitor and contribute to guidance in key regions including US, Europe, Japan and China
Provide regular updates to all GRSs and other stakeholders / internal groups
Identify priority areas and provide input to Regulatory Policy
M.S. degree with eight (8) years of IVD / regulatory affairs / drug-related development / medical research activities or B.S. degree with ten (10) years of IVD / drug-related development / medical research activities
At least five (5) years of experience in IVD plus two (2) years in regulatory affairs
Working knowledge of US and international medical device regulatory requirements
Experience with FDA interactions and submissions
Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics
Good understanding of IVD development process
Excellent communication skills, verbal and written, and ability to effectively communicate with cross-functional teams
Strong analytical skills and ability to find effective solutions for varied and complex problems
Demonstrate leadership and project management skills, working across cultures, interpersonal and influence-management skills
Fluency in the English language
Sound knowledge of MS Office: Word, Excel, PowerPoint and MS Project
Advanced technical degree Ph.D., D.V.M., M.D. or Pharm. D. in life sciences with five (5) years in IVD / regulatory affairs / drug-related development / medical research activities
Experience in oncology
Familiarity with regulatory issues and challenges associated with Drug/Diagnostic co-development
Recent experience with IVD/drug co-development projects and understanding of drug development process in oncology

250

Regional Regulatory Affairs Resume Examples & Samples

At minimum 10 years’ experience in the pharmaceutical industry, preferably in Biologics in the areas R&D, Regulatory Affairs
At least 5 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience
Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities
Understanding of the principles of GMP, GCP and GLP
Demonstrated leadership ability. Keeps a team focused to deliver according to agreed milestones, can inspire and motivate while providing corrective feedback, if required

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