Regulatory Manager Resume Samples

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L Homenick

Lorine

Homenick

11279 McGlynn Harbor

Dallas

+1 (555) 498 7020

11279 McGlynn Harbor

Dallas

Phone

p +1 (555) 498 7020

Experience Experience

Los Angeles, CA

Regulatory Manager

Los Angeles, CA

Hegmann-Lindgren

Los Angeles, CA

Regulatory Manager

Manage and provide feedback and support to contract resources providing regulatory intelligence to Shell
Provide and manage regulatory and scientific input to confectionery product and process development
Plan and execute regulatory activities in AME and find innovative registration approaches within the legal regulatory framework
Working with clients to develop or review their ORSA
Providing advice and assurance on matters of capital, risk management and governance
Plan and execute regulatory activities in Zambia and find innovative registration approaches within the legal regulatory framework
Provide country specific regulatory expertise to global product development teams

Detroit, MI

Quality / Regulatory Manager

Detroit, MI

Crooks, Abernathy and Grimes

Detroit, MI

Quality / Regulatory Manager

Maintain ISO certification, perform audits and work with auditors to improve processes
Support the Management of Daily Improvement (MDI)
Establishes (through quality monitoring), performs follow-up and ensure closure of corrective and or preventive actions
Performs all scheduled quality monitoring activities (including internal audits, management evaluations, inspections, supplier audits, etc.,)
Provide management with an independent assessment of corrective and preventive actions, their implementation and completion
Be the designated SMS Manager
Implements, monitors and coordinates improvements to the Quality and Regulatory System

present

Boston, MA

Compliance & Regulatory Manager

Boston, MA

Orn, Reichert and Abshire

present

Boston, MA

Compliance & Regulatory Manager

present

Provide staff members with leadership, guidance, mentoring, coaching, and feedback against performance and development objectives
Contribute to process improvement initiatives and represent QA on project teams, management meetings, and other internal forums
Developing a compliance framework
Active involvement in developing new business opportunities and working closely with other departments within the firm to do so
Provide department quality metrics and tracker information to Senior Management monthly
Developing compliance policies and procedures
Manage a QA auditor team responsible for lab data review, lab investigations review, methods/protocol approvals and COA issuance

Education Education

Bachelor’s Degree in Food Science

University of Arizona

Bachelor’s Degree in Food Science

Skills Skills

Ability to apply detailed knowledge of organizational procedures to make independent decisions and serve as a credible resource for a senior management team
Great communication, organization and attention-to-detail skills
Strong interpersonal skills and ability to interact positively with all functions
Good understanding of product supply chains and organizations involved globally and being able to effectively contribute within these chains and organizations
Demonstrates strong teamwork skills and is able to lead, collaborate and work effectively in teams across different businesses, functions and geographies
Ability to adapt regulatory knowledge/experience to the Agilent environment and develop solutions that are appropriate for Agilent
Basic knowledge of hazard communication regulations in EAME region
Excellent knowledge of MS Office (Word, Excel and Power Point)
Strong written and verbal communication; ability to present to various audiences’ levels
Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance

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15 Regulatory Manager resume templates

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Regulatory Manager Resume Examples & Samples

Advise clients with deep technical insights and build credibility based on an understanding of their challenges related to technical matters. Assist in preparing risk assessments and annual plans for financial services clients. Provide high quality, professional day-to-day execution of engagements and projects in line with firm risk management practices for the financial services practice
Develop ideas to expand EY’s current offerings and initiate discussions with clients. Identify and communicate findings to senior management and client personnel
Supervise project work prepared by more junior professionals, providing feedback and guidance on quality outputs
Understand firm service offerings and mentor associates, interns, and new hires
Regulatory experience at the FSA/ FCA, a FTSE 100 Financial Services organisation, one of the other Top 4 consultancies, or another Advisory firm
Knowledge of CASS, governance, conduct risk, new regulatory developments such as MiFID 2 would be beneficial
Strong academic background which could include the following: 2:1 degree, CII Exams ( FPC / AFPC), CISI Level 4, Prince 2, CeMAP, CeFA and / or Other Financial Services qualifications

Emeia FSO Regulatory Manager Resume Examples & Samples

Engagement planning, management, and leading teams in remediation engagements and on-going compliance work
Supporting bids and proposals for new client opportunities and grow existing valued relationships
Work effectively as a team member sharing responsibility, providing support and updating senior members on progress; and
Mentoring staff and conduct performance reviews and contribute to performance feedback for staff
Strong academic background, ideally to a degree level or equivalent
Knowledge of the UK and European financial regulatory environment (knowledge of the global environment an advantage)
Regulatory compliance work experience. Consulting experience and/or a relevant professional qualification would be an advantage
Technical knowledge of financial products or regulated activities (e.g. Anti-Money Laundering, Know Your Client, FATCA and Suitability Reviews)
A focus on one or more of the following areas: Wholesale Banking, Retail Banking, Wealth, Asset Management and Insurance
Enthusiasm to be involved in marketing activity and developing the Managed Services team; and
A willingness to travel

Business Risk & Regulatory Manager Resume Examples & Samples

Administer and manage the risk, regulatory and tax heat map
Perform operational error analyses and set up meaningful statistics
Review and endorsement of new policies
Prepare and lead the IPS CFMP Risk, Regulatory and Tax Committees
Represent CFMP in regulatory related working groups, project meetings, etc
Partner with various stakeholders to ensure that the business is adequately
Bachelor / Master degree, preferably in Law or Business Administration
Experience in Banking / Finance within a Risk & Regulatory, Compliance, Audit or comparable department
Mature and able to work independently with minimal supervision
Fluency in German and English both oral and written

Risk & Regulatory Manager Resume Examples & Samples

Oversee and provide quality assurance for the Op Risk Events process managed by the Op Risk Analyst
Provide support and guidance to the Op Risk Analyst with regard to significant events, escalation to Senior Management and contested issues
Review loss calculations to ensure fair treatment of clients
Oversee and provide quality assurance for the monthly collation and reporting process conducted by the Compliance Administrator
Facilitate the annual ICAAP update including acting as secretary for the ICAAP Working Group
Gather and prepare documentation and obtain appropriate sign off of the ICAAP
Maintain documentation for internal record keeping and external regulatory review purposes
Assist the Senior Risk Manager as necessary including
Management information development
Preparation of management committee and Board reports
Maintenance and development of relevant operational risk policies and procedures
Any other duties as deemed appropriate by the Senior Risk Manager
Work as a member of the Op Risk Team to ensure linkages between distinct risk management activities (such as RCSA, KRIs and Op Risk events)
Manage the Risk & Compliance business continuity plan and strategy
Contribute to Committee and Board meeting pack preparation
Experience in an Operational Risk
Experience in the asset management industry (including wealth management or investment consultants) preferable
Completion of a risk or investment management certificate (e.g. IMC) preferable
Experience reviewing, facilitating or contributing to internal capital planning including stress testing, reverse stress testing and orderly wind down
Experience with management reporting and escalation of issues
Experience with development and analysis of Key Risk Indicators
Familiarity with Risk Control Self-Assessment and other business risk assessment processes
Ability to work independently, research and investigate issues as needed, and present results in a timely and professional manner
Strong time management and work prioritisation skills
Team player who demonstrates flexibility and desire to share information and support junior members of staff in their development

Regional Management Team-risk & Regulatory Manager Resume Examples & Samples

Review and analyze client portfolios from a risk and suitability perspective, including account activity, transaction history and client correspondence
Proactively identify inconsistencies between client account activity as compared to internal investment policy guidelines, the client’s stated investment objectives, risk tolerances and portfolio goals, and work with PWM Teams to address
Present at bi-weekly Risk Committee meetings on accounts with the highest levels of risk. Collaborate with Committee Members and PWM Teams to develop and implement risk mitigating recommendations by creating customized risk reports for client presentation purposes and establishing / imposing risk thresholds when appropriate
Keep PWM Teams apprised of regulatory changes and their potential impact to the PWM business while also educating PWM personnel on the internal policies and controls designed to comply with such changes
Collaborate with PWM teams, Product Teams and the Strats Team to identify accounts posing excessive economic risk to the client or the firm. Advise Private Wealth Advisors on how to communicate and address potential issues with clients and, where necessary, set risk thresholds
Ensure that client profile changes, portfolio reviews and noteworthy account activities are documented appropriately through investment and relationship notes
Assess potential risks associated with trades/account activity requiring additional approvals due to risk thresholds/controls being potentially exceeded
Coordinate regular reviews of account types with heightened supervisory requirements
Manage and participate in various regional supervisory reviews of PWM accounts including the Annual Account Review
Analyze metrics to identify operational and reputational risks while escalating findings to relevant stakeholders involved in related processes
Work with Strats Team to develop specific risk analytics / reporting to be used internally and/or externally with clients
Report regularly to the US PWM COO and PWM Region Heads in each coverage office, keeping them apprised of key client and business risks and the steps being taken to mitigate them
Minimum of 5 years of experience in a financial organization, preferably in the private wealth high net worth area or a compliance/legal function
Experience in risk analysis and management and/or regulatory reform strongly preferred
Working knowledge of products typically held in private wealth management accounts including structured products and derivatives
Excellent interpersonal, leadership and communication skills and a desire to work in a team-oriented environment
Retain good judgment and discretion, particularly when placed in demanding situations
Outstanding analytical skills; ability to work with detailed financial or other data and understand and communicate commercial implications
Self-starter who takes ownership and can lead/manage projects independently
Series 7, 9 and 10 required (must be obtained within six months of employment)

Senior Regulatory Manager Resume Examples & Samples

6 years of relevant accounting experience
Strong regulatory reporting knowledge, including experience with FR Y9C, Call Report, FFIEC 009, etc
Strong data aggregation skills
Excellent Microsoft Excel knowledge
Strong understanding of US GAAP
Experience in databases and systems
Peoplesoft / Hyperion experience

Human Resources Regulatory Manager Resume Examples & Samples

Responsible for all HR regulatory matters for the APAC region – from monitoring and understanding regulatory requirements (in partnership with the relevant location and external subject matter experts) to translating into deliverable solutions for the firm
Subject Matter Expert with the ability to understand the impact of regulatory and other external and internal changes on the Firm’s business
Maintain a detailed understanding of the regulatory restrictions placed on compensation structures and people practices and the impact on the Firm’s business, developing proposals to manage that impact and updating senior management
Collaborating with the rest of the Compensation & Benefits team and APAC HR team, as well as key Global stakeholders, to produce integrated solutions
Ensuring HR Business Partners (including HR Country Heads) are fully informed and onboard with the regulatory landscape
Tracking the progress of new HR-related regulations through relevant approval processes (especially those related to compensation and performance management aspects of HR)
Reviewing HR regulatory guidelines, etc. to determine impacts on the Firm’s business and employees – this will involve working closely with functions across the Firm in APAC and globally (e.g., Legal, Compliance, local HR)
Delivering updates and presentations for senior management on issues and proposed solutions
Ensuring compliant implementation of new regulations (including incorporating local requirements within the global framework)
Producing responses to regulators throughout the APAC region as well ad-hoc queries on specific issues
Overseeing the Firm’s statutory regulatory and public compensation disclosures for APAC
Excellent interpersonal and communications skills; it will be essential to quickly build credibility with the key internal stakeholders
Excellent and proven quantitative analytical skills

Regulatory Manager Resume Examples & Samples

Initiates approval tracking in database
When requested by PI, initiates IND application to the FDA
Will follow progress of on-line submission. Will remind investigators to sign off on submission approval if not done within a few days. Will promptly initiate response to any stipulations or assist investigators in formulating a response
On notice of IRB approval, will notify café database person so that protocol and Informed Consents can be posted on web site and the set up for patient registration can be initiated. Protocol will be also be added to the Protocol Priority List and coordinators will be notified
Submits promptly any revisions or amendments and Continuing Reviews to the IRB
Gives approved amendments/revisions to database managers to update data management tools and posting on web site
Ensures that External Serious Adverse Events are submitted from sponsors
At all times, keep Study File updated for source document tracking
Submits study to the Central IRB (CIRB) with Spanish version of IC
For Continuing Review yearly will submit CIRB approvals to IRB to have date stamped on Informed Consent
Submits signed CTSU form to CTSU

Human Resources Regulatory Manager Resume Examples & Samples

Special focus on providing strategic advice and guidance for our China businesses on compensation and HR regulatory matters
Ensuring HR Business Partners (including HR Country Heads) are fully informed and on board with the regulatory landscape
Written and spoken Chinese language skills would be beneficial

Risk & Regulatory Manager Resume Examples & Samples

College degree is requested and 10 years of experience
Experience and knowledge of Risk Control Self-Assessment, preferred
Issue/Incident Management experience, preferred
Ability to communicate effectively to all levels within the firm and externally
Proven ability to execute and meet deadlines in a dynamic environment
Former control/process testing experience, a plus
Audit facilitation/coordination experience, a plus
Technical expertise with Microsoft Access, Excel and/or SQL Databases, a plus

Financial Services Regulatory Manager Resume Examples & Samples

Organising, managing and delivering impact assessment or gap analysis engagements on various regulatory matters (MiFID II, FATCA & CRS)
Delivering workshops and training sessions on various regulatory topics (MiFID II, FATCA & CRS)
Supporting proactively the sales initiatives in MiFID II, FATCA & CRS and contributing to our substantial growth (support in sales pursuits, point of views, conferences, articles, MiFID II, FATCA & CRS decks, etc.)
Helping in the management of our regulatory Advisory practice (internal coordination, coaching of team members, coordination with EMEIA, etc.)

Regulatory Manager Resume Examples & Samples

At all times, keep Study File updated for source document tracking (sponsor correspondence, revisions, IRB correspondence.)
Prepares Regulatory files for sponsor site visit review on request
Notifies study coordinators of study accrual closure
At study termination, closes study and terminates study at IRB
Stores records for 15 years after termination

WM Regulatory Manager Resume Examples & Samples

Collaborate closely with colleagues from other disciplines (legal, tax, markets, product management, etc.) to ensure solutions are agreed and complete
Perform analysis of new requirements and propose and develop feasible solutions
Analyze policies and other documents to support the identification and extraction of rules
Design, implement and test rules in the rule engine, taking into account the impact on the overall rule set
Business Rules Analyst / Business Rules Consultant with experience in harvesting, extracting, and eliciting business rules from SME's. Deep knowledge of Business Rules Methodology
Strong analytical skills and quick understanding of complex procedures and processes

Information Security Audit & Regulatory Manager Resume Examples & Samples

Bachelor’s degree in related field or equivalent combination of education/experience
10 years of Information Security experience or Technology Audit experience or a mix of the two
Experience working with internal and external auditors including regulators
Professional certificate desirable: CISSA, CISA, CRISC
Strong understanding of O&T Risk domains
Effective leadership skills
Strong written and oral communication skills, including presentation skills
Strong understanding of policies and regulations that affect O&T risk control
Able to communicate effectively at all levels of the organization
Self-motivated, able to manage deadlines in a fast –paced environment requiring strong project management and multi-tasking skills

Regulatory Manager Resume Examples & Samples

4+ years of experience in Pharmaceutical Product Development
Bachelor's / Master's Degree and/or Ph.D. in Biochemistry, Chemistry, Biology or a related Pharmaceutical field
Significant experience in CMC regulatory affairs with a strong Biologics background
Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance
Experience in directing interactions with Regulatory authorities

Regulatory Manager Resume Examples & Samples

Follow up that team, cross-functional processes and procedures are easy to follow and complied with in the team
Follow up on team objectives to ensure they are met and strategies are implemented
Responsible for giving input to the Regulatory Operations budget in collaboration with Head of Submission Management,
Communicate decisions and initiatives within the team and in cooperation with stakeholders
Ensuring deployment of strategies and targets/KPIs in the section
Ensure Submission Execution and Lifecycle Management is in compliance with current regulations and business needs internally and with Sourcing Partner
People managing the direct reports
Building project management and knowledge sharing capabilities in the Submission Management department
Enhancing regulatory and product lifecycle understanding and ways to transfer it into regulatory activities in the department
Securing the necessary training and development of employees
Provide employees with the needed support to drive performance
Organise Induction and training for new personnel in Regulatory Submission Management Dublin
Ensure constructive and close working relationships with RA, affiliates, regional offices and our global sourcing partner as well as the manufacturing site
Sc. or equivalent third level qualification
Minimum of 5 years' experience in the pharmaceutical industry
2+ years' experience within management - resource management, capacity management, target management, performance management, competency development, motivation of employees, situational management etc
3+ years of experience working within different areas of Regulatory Affairs
Training within management and leadership

Regulatory Manager Resume Examples & Samples

Creation of SDS documents for finished products and in-house ingredients
Creation of TTB Formulations for applicable products
Issuance and maintenance of certificates to comply with NAFTA regulations
Ingredient Classification
Regulatory support to the Business Continuity Process
Execution of SRA Commercialization Review for CPSNA plants
Other Regulatory certifications as required by customers and third parties
Liaise with Corporate SRA, Legal and Formula Governance teams
Advanced Product Formula Knowledge
Advanced knowledge of the formula approval process
Basic knowledge of food ingredient uses and functionality
Basic knowledge of regulatory compliance requirements related to ingredients and formulas
Knowledge of Concentrate Plant operation
Operational Excellence Knowledge
Basic Knowledge of regulations and actions required for the safe transport of hazardous materials
Organization and planning
Critical, strategic, forward thinking
Relationship development and management
Clear and succinct communication
MS Excel and/or MS Access skills
Basic SAP navigation

Regulatory Manager Resume Examples & Samples

Experience implementing and advising on regulatory/compliance programmes over the past 5 yrs + in the financial services (and commensurate qualifications), call me to discuss
An Audit or Compliance qualification (desirable)
An understanding and knowledge of Irish Banking Prudential regulation (highly desirable)
Strong team player, confident/experienced enough to work autonomously
Excellent time management and prioritizing skills
Ability to adapt to change and thrive in a dynamic banking environment

Business Risk & Regulatory Manager Resume Examples & Samples

Identify, assess and analyze operational risk and regulatory topics and define
Bachelor / Master degree, preferably in Economics, Law or Business Administration
Ability to work under pressure and stringent guidelines and to manage a

Compliance & Regulatory Manager Resume Examples & Samples

Provision of technical expertise to assist a broad range of clients to manage their relevant regulatory requirements
Active involvement in developing new business opportunities and working closely with other departments within the firm to do so
A key role in planning and managing projects as required, meeting all deadlines in a timely manner
Developing a compliance framework

Regulatory Manager Resume Examples & Samples

Initiates tracking of the approval process in the Cancer Center database
Will follow progress of on-line submission. Will remind investigators to sign off on submission approval if not done within a few days
Will promptly initiate response to any IRB stipulations or assist investigators in formulating a response
On notice of final IRB approval, will notify café database person so that protocol and Informed Consents can be posted on web site and the set up for patient registration can be initiated. Protocol will also be added to the Protocol Priority List in order for all research staff and investigators to have a list of open trials
Gives approved amendments/revisions to database staff for updating the web site
At all times, keeps Study File updated for source document tracking (sponsor correspondence, revisions, IRB correspondence.)
Notifies research staff of study accrual closure
At study termination, closes study in IRB
2 Submits study to the Central IRB (CIRB) with Spanish version of IC
4 Submits signed CTSU form to CTSU

Regulatory Manager Resume Examples & Samples

Providing advice and assurance on matters of capital, risk management and governance
Working with clients to develop or review their ORSA
Working with clients to develop or review their reporting requirements under Solvency II
Interpreting and preparing for regulatory change; identification of and development of new propositions
Advising clients on emerging or identified regulatory themes

Regulatory Manager Resume Examples & Samples

Prepare and update the CMC sections of global Marketing Authorizations
Develop regulatory post-approval filing strategies and prepare CMC variations for global products
Prepare CMC regulatory documents accurately, completely and on-time
Manage post-approval manufacturing changes for products manufactured at facilities and contract manufacturers
Prepare responses to Health Authority queries and requests for CMC information, as appropriate
Maintain fluency in emerging global CMC regulations and content/format requirements
Support market affiliates with regard to CMC issues
Develop strong working relationships and act as primary Global CMC interface with global Regulatory Affairs colleagues and manufacturing sites
Work independently (where necessary) through the full-scope breadth and depth in the post-approval CMC discipline

Remuneration & Regulatory Manager Resume Examples & Samples

Manage in the area of Reward Governance and Regulation, ensuring that appropriate structures, policies and practices are in place across the Region
Keeping abreast of regional regulatory issues and evaluating Citi’s remuneration policies, practices and policies against a continuously evolving remuneration regulatory landscape in the UK, across the EU with an understanding of the US regulator’s requirements
This role aims to add significant value by contributing to the shaping of Citi’s remuneration policy, processes and practices to ensure compliance from a remuneration regulatory perspective in the UK and across the EU but also remain competitive
Evaluating Citi’s remuneration policies and practices against a continuously evolving remuneration regulatory landscape in the UK, and across EMEA with an understanding of the US regulator’s requirements
Keeping abreast of regional remuneration regulatory issues
Assisting with the implementation of remuneration regulatory requirements and compliance with the UK /EMEA regulators as necessary whilst maintaining Citi’s Global approach to remuneration regulatory issues
Key contributor to shaping and application of Citi’s remuneration policy, processes and practices from a UK/EU/EMEA perspective
Shaping and developing Citi’s reward structures to ensure compliance with regulatory requirements whilst maintaining Citi’s Global Compensation philosophy and remaining competitive
Working closely with the wider Reward team and other internal stakeholders i.e. Risk and Compliance, Reward and Mobility, Legal, and in particular the NY Corporate Compensation Team
Training HR colleagues and key stakeholders on practical implementation of remuneration regulatory requirements from a UK/EMEA/US perspective
Ability to manage, coach and develop junior members of the team
Delivery on annual targets set by HR and Reward and Mobility Management
Assisting with audit responsibilities in connection with regulatory remuneration matters
Knowledge of UK and global regulatory issues
Practical experience of management within a Compensation and Benefits function with regional and/or global responsibilities
Proven track record in adding value and delivering on key projects
First class client handling and consultancy skills will be vital, given the interaction required with Country HR staff, senior management and multiple businesses across the EMEA region
Strong record of achievement and proven success in management of projects involving multiple stakeholders on a regional / global level
Management of compliance process on a regional / global level and ability to lead/manage/contribute to negotiations with local Revenue authorities and Compliance / Regulatory bodies
Excellent interpersonal, communication and diplomacy skills with the ability to work successfully both as part of a team and on own initiative as well as the ability to inspire confidence from others
Pro-active approach to work-load, consistently striving to add value to the business and to contribute to wider Reward and Mobility and HR projects and initiatives
Excellent analytical and numerical skills with the ability to effectively review internal / external advice and to make appropriate recommendations to senior management
Bachelor degree essential
Legal/Tax background would be preferable but not essential for those with relevant experience

Cn.legal.specialized.regulatory Manager Resume Examples & Samples

1 LS Creation
2 Maintenance and update of branded tracking sheets
3 Management of bridge stock alerts and customer inventory in case of HP expiration
4 Creation of label master files and label requirements & label artworks and submission to Lachen and FAMO
5 Maintain and extend China Affiliate master file for Travel Retail China
6 Checking of HP status with the local RA Team
7 Reporting on HP status and label availability
8 Checking of label & HP readiness reports
9 Coordinate the Travel Retail Hainan assortment with travel retail regional team
2 Lead projects such as introduction of new brands into China for all regulatory related
3 Be the core communication person for labeling/regulatory with China Affiliate, TR China (different Brand Sales and Education team), TR APAC Singapore Office, TR Global New York Office and Lachen DC
4 Be the regulatory expert for TR China, monitor and track regulatory changes/updates particularly focus on China market information, foresee potential risks if any, and provide function support/possible solutions to internal stakeholders, including Sales team, marketing team, DC team, HR and etc
5 Labeling team daily management
1 Document Travel Retail internal work procedures
2 Ensure all assortments (including Hainan) are HP compliant
3 Sets up annual performance target and development plans with the direct reports and follows up on them
4 supervises introduction and training for new team members
5 Supports the team in daily questions and problems
6 Balances and manages workloads and absences within the team, and act as backup for the Labeling Executives
Tertiary education
Education and/or experience in Regulatory Matters (HP& Labeling)
Experience in a similar role in an international cooperation, and in customs & import regulations preferred
Strong communication
Fast learner, self-motivated & attention to details
Team building ability and coach capability
Service minded personality
Project Management skills
Agility and flexibility
Ability to liaise and communicate pro-actively with people of all sorts of backgrounds and levels
Face challenges with a fact-driven and professional approach to drive resolution
PC literate & good working knowledge in computer applications software

Regulatory Manager Resume Examples & Samples

Support all regulatory filings and associated activities for clients at the CPUC for Energy Efficiency Programs Funding proceeding and other federal, State or local regulatory agencies, departments, offices and/or funding opportunities
Review CPUC proceeding documents (Order Instituting Rulemaking, Administrative Law Judge/Commissioner Statements, Proceeding Scoping Documents, Proceeding Participant Comments/Reply Comments, Draft Decisions, Final Decisions)
Review similar documents in other federal, State or local regulatory agencies proceedings
Respond to specific requests for data, information or other needs from the CPUC or other regulatory proceeding administrators
Provide program-related advisory services related to legislative, regulatory, utility administration, strategic planning , public affairs, fiscal management, and other areas in support of the administration and management of CPUC Programs and in support of activities required for the CPUC proceedings for Energy Efficiency Programs
Represent ICF clients, as needed, at CPUC and/or other regulatory agency, federal/state/local offices, and other funding source venues; provide minutes of meetings and updates of these representations
Advise a multi-functional project team comprised of technical and marketing specialists (some ICF internal staff and some subcontractors) to ensure timely and professional completion of all tasks and achieve specific program goals
Developing and implementing long-term business plans for growing energy efficiency work in the residential, commercial and industrial sectors
10+ years of CA CPUC Regulatory experience supporting, managing, and responding to electric and gas energy efficiency regulatory filings, with experience in residential, commercial, industrial, and/or local government energy issues
Experience managing regulatory activities, compliance, and providing representation for projects with public sector clients, including providing quality control and budget accountability
Senior level experience in the CA EE market with related energy efficient and renewable technologies
Excellent verbal, interpersonal and written communication skills
Ability to apply detailed knowledge of organizational procedures to make independent decisions and serve as a credible resource for a senior management team
Ability to be flexible to handle multiple priorities

Regulatory Manager Resume Examples & Samples

Bachelor's degree in Accounting, Business, Computer Science, Economics, Finance, Information Systems or related degree required
Seven years’ consulting and advisory experience in the Financial Services Industry (Commercial and/or Retail Banking, Compliance (Consumer Protection and/or AML), Regulatory) or related consulting experience
Experience in providing consultation services to financial institutions, particularly banking institutions in one or more area the following areas
Consumer Protection Compliance
Certified Regulatory Compliance Manager
Dodd-Frank Act Compliance
Resolution Planning
Enforcement Action Remediation
Exceptional client service with a demonstrated ability to develop and maintain outstanding client relationships
Developing risk management programs, including risk monitoring and reporting, risk assessment and prioritization, and the facilitation of the definition of an organization's risk appetite and risk tolerance in alignment with their organization's strategy
Deep knowledge and exposure to corporate compliance engagements, including developing, analyzing and assessing corporate compliance programs; constructing, monitoring and auditing programs; managing internal risk assessment and investigations, collaborating with organization management to integrate compliance controls into the scope of existing business practices; developing and delivering compliance training, and managing incident management systems
Ability to participate in the creation and tracking of engagement work plans, timelines, budgets, project management, and resource allocations
Maintain active communication with clients to manage expectations, ensure satisfaction, and become a trusted business partner
Identifies and addresses client needs: building, maintaining, and utilizing networks of client relationships and industry involvement and communicating the value proposition
Strong administrative skills: project workflow, budgets, billing and collections; and preparing and/or coordinating complex written presentation materials
Ability to think independently and be a thought leader, professional demeanor, a can-do attitude and other qualities that include decisiveness, self-initiative, and high energy
Detail-oriented, able to work according to schedules and workplans, able to ask good questions and request help as needed
Examination experience or extensive knowledge with one or more of the following agencies (FRB, OCC, FDIC, FinCEN, or SIFMA) and/or ex-senior AML Officer from a nationally recognized institution
8 – 12 years of relevant experience
Able to work with and manage teams of diverse consultants on complex engagements
Extensive experience working with and providing advice on KYC / AML and OFAC Sanctions programs
Solid knowledge of 1st and 2nd lines of defense
Has solid hands on experience working in two or more of the following areas
Independent reviews
AML and OFAC risk assessments
KYC improvement initiatives
Vendor solutions in KYC, Transaction Monitoring, Case Management or OFAC
Customer risk rating and model validations
System validations
Bachelor’s or Master’s degree
CAMS, CAMS-Audit, or ACFCS certified
PMP optional

Regulatory Manager Resume Examples & Samples

10-15 years experience
Strong marketing and consulting sales skills
Superior analytical skills sufficient to enhance large financial institution, banking or capital markets projects
Significant examination experience or knowledge with one or more agencies including Federal Reserve System, Office of the Comptroller of the Currency, FDIC, Consumer Financial Protection Bureau, Bank of International Settlements, or equivalent
Skilled at coordinating through matrixed management structure
Strong people management and project facilitation skills, especially with leading and facilitating teams and guiding transformational change
Significant subject matter expertise in the design and implementation of large institution risk management programs in at least three of the areas noted
Corporate Governance,
Enterprise Risk Management,
Market Risk Management,
Credit Risk Management,
Counterparty Credit Risk,
Operational Risk Management,
Funding/Liquidity Risk Management and Planning,
Capital Adequacy and Planning,
Stress Testing (Dodd-Frank),
Recovery and Resolution (Dodd-Frank),
Compliance Programs,
Consumer Compliance,
Advanced Anti-Money Laundering Expertise
Master’s Degree in business related field (e.g. finance, economics)

Regulatory Manager Resume Examples & Samples

Manage risk and ensure regulatory compliance by providing support for 3M PI Labs, products, and business teams
Work with 3M PI Labs to drive regulatory process requirements
Lead global product regulatory compliance and Life Cycle Management (LCM) activities
Provide global regulatory consulting/guidance to development/business teams and division to support new products/growth and ensure continuing sales/compliance for existing products
Provide customer support – address customer inquiries and data requests
Manage division, industry, and corporate expectations around product regulatory data requirements
Support global knowledge sharing of 3M PI regulatory trends/requirements by representing 3M on industry teams to track trends & stay abreast of issues affecting 3M PI business
Maintain Regulatory Scorecard to track and report division progress
Lead U.S. team of direct reports and provide oversight and direction to global regulatory support
Drive global connectivity to ensure comprehensive and consistent approach across 3M PI
Minimum of five (5) years of experience in a regulatory role
Master’s degree or higher in a technical discipline from an accredited institution
Product Responsibility Liaison (PRL) internal or similar external experience
Minimum of three years supervisory/management experience
Experience with healthcare, food contact, and water regulatory requirements
Experience with 3M processes and utilization of corporate support (applies to internal applicants only)
Ability to work effectively and influence across 3M matrix (internal) or another corporate environment (external)
Healthcare business regulatory experience, including pharmaceutical and medical device experience
Strong process skillsets
Demonstrated ability to champion regulatory process and drive change
Experience leading global cross-functional teams
Microsoft Office proficient
3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity, age, disability, or veteran status

Regulatory Manager Resume Examples & Samples

60% Local Execution
Minimum Bachelor degree in related discipline
Minimum working experience of 5 or more years in handling product regulatory registration
Familiarity with domestic and international regulatory requirements for product registration in Asia Pacific
Proven track record of successfully working in an international, multi-cultural environment
Proven project management skills and is able to multi-task
Excellent command of English language is a prerequisite
Incumbent must be a highly motivated “go getter”/”do it yourself”- type of individual with a passion for taking ownership, getting results and making progress
Good understanding of product supply chains and organizations involved globally and being able to effectively contribute within these chains and organizations
Good business sense and commercial comprehension of the animal feed industry

EMC Regulatory Manager Resume Examples & Samples

Plans, manages, and develops the EMC and compliance qualification of multiple Head unit and Amplifier programs, requiring both development engineering and execution
Manages both internal and external testing, consisting of EMC and compliance testing
Coordinate EMC and Compliance Qualification group: coach and lead team towards achievement of group goals; hire, train, allocate resources and develop processes
Interface with the entire Product Engineering group to ensure that all necessary qualification activities are included in the project plans and that all planned qualification activities occur
Creates test report templates and test plans for all products
Interface with other Harman organizations to ensure all qualification issues are resolved in a timely manner
Establishes company policy, technical standards, and procedures used in testing our products by keeping abreast of current and new scientific test methods and developments affecting our products warranted by such developments
Serves as the technical specialist on EMC and regulatory Compliance testing and support Product Engineering
Represents and works to improve Product and Process Quality within Product Engineering teams
Must be able to effectively communicate with internal/external customers and internal lab team members and other stake holders
BSEE, BSEET, BSCS, BS Physics or equivalent experience
5+ years EMC qualification, 3+ years’ managerial experience, automotive industry background required
WORKING KNOWLEDGE
Advanced test solutions knowledge for automotive industries

Quality Compliance & Regulatory Manager Resume Examples & Samples

Lead the implementation of the Food Safety Management system (FSSC 22000)
Maintain FSCC 22000 Food Safety Management system
Assure compliance with HACCP requirements
Assure compliance with Pre-requisites program
Ensure training and education for the food security team, as well as for the operators to monitor critical points
Ensure compliance to local and federal food safety standards
Develop employees through training, annual review, monitoring, and mentoring
Maintain a team environment among department and supervisory staff
Promote and maintain a safe work environment
Work closely with plant operations teams in the areas of quality program management, inspection coordination and testing requirements
Maintain current knowledge of trends and changes affecting food safety and develop and recommend appropriate program changes to ensure governmental compliance
Advising Management staff of any quality control and food safety issues in addition to presenting plausible solutions
Technical knowledge of quality and food safety
Experience dealing with regulatory agencies (i.e. FDA)
3-5 years’ experience in Quality Assurance or Food Safety Leadership
Experience in developing, maintaining and enforcing
Good Manufacturing Practices (GMP)
HACCP certification program design and implementation
Food Safety documentation and reporting
Submitting and implementing corrective/preventive action plans
FSSC 22000 requirements
Technical knowledge of Food Manufacturing Processes
Technical knowledge of Sanitation and microbiology
Proficient in Microsoft Office, Meridian, SAP, RedPRerei, KPOG, eQCMS
Strong leadership skills
Strong verbal and written English communication skills
Strong implementation and execution skills
Analysis and interpretation of results
Good organizational and planning skills
Ability to be relatable, personable, and productive within a team environment

Regulatory Manager Resume Examples & Samples

Bachelors, Masters or University Degree or equivalent in Engineering or Scientific discipline with 10+ years relevant business experience
5+ years of experience in IVD/medical device industry
Profound knowledge of international medical device / IVD regulations such as FDA QSR, EU IVDD, MDD, … and related standards such as ISO 13485, ISO 14971, IEC-61010-2-101
Experience in establishing and managing a global regulatory strategy (including registrations, product listings / submissions) for medical device / IVD products
Demonstrated strong management and leadership skills in implementing program/organization strategies
Strong experience in integrating, guiding, and influencing global resources across several complex departments or functions
Demonstrates strong teamwork skills and is able to lead, collaborate and work effectively in teams across different businesses, functions and geographies
Has a sensitivity for working with other cultures
Willingness to work globally within different time zones
Technical Knowledge of Product Regulations including Safety, EMC, and Agilent Environmental Standards
Experience with Agilent LSAG’s products
Experience working in mixed product environment: medical device, pharma, non-medical/clinical regulated

Cmc-regulatory Manager Resume Examples & Samples

Actively contribute to the development and implementation of regulatory strategy for assigned projects
Translate regulatory requirements into practical, workable submission plans
Coordinate the authoring, review and comment resolution for related submissions
Interface with external regulatory groups, such as contract manufacturers, development partners, consultants and technical writers
Act as liaison between Regulatory Affairs and other functional areas
Represent Regulatory Affairs in cross-functional team meetings
Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments
Author and review standard operating procedures (SOPs)
Experience working with biologics is highly desirable
Experience with regulatory submissions in Common Technical Document format is essential

Compliance & Regulatory Manager Resume Examples & Samples

Manage a compliance /regulatory team responsible for Compliance activities and Regulatory activities at the site
Manage a QA auditor team responsible for lab data review, lab investigations review, methods/protocol approvals and COA issuance
Manage/lead audits of Catalent Somerset site to assure compliance with EU and FDA CGMPs, Corporate, and Pharmaceutical Development standard operating procedures and policies
Support site in compliance and regulatory matters as required
Oversee the process for effectively documenting audit findings in Audit Reports and obtaining responses in a timely fashion
Participate in customer audits of the facility as required
Liaise with internal and external customers as required for all aspects of audits
Act as primary contact with customers for compliance and regulatory matters
Oversee and participate in activities in preparing site for inspections by US and foreign regulatory authorities and corporate auditors and participate in these inspections
Ensure that written responses are provided and appropriately address the observations for customer audits, internal audits, corporate audits, and regulatory inspections. And those responses are completed as committed
Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met
Provide overviews of audit findings for presentation to management as required
Monitor and oversee the CAPA program, trends, findings, and evaluate CAPA effectiveness
Hold regular CAPA meetings with the appropriate departments to ensure completion of CAPAs and their effectiveness
Monitor, assess, and report on Trackwise Problem Reports - CAPA, Change Control, Deviations, Follow-ups, and Tasks etc. by meeting with senior level management team on a regular basis
Ensure that weekly Trackwise meetings are held and that PR owners obtain resolution for open PRs in a timely manner
Ensure that the Trackwise SOPs for all quality systems are current and are being followed by the site as stated
Roll out new Compliance programs for the site: creating SOPs and performing training for these programs
Provide department quality metrics and tracker information to Senior Management monthly
Approve department procedures and assist in the development of new procedures and/or revisions of existing procedures as required
Support the Change Control Program ensuring that it meets current regulatory requirements
Contribute to process improvement initiatives and represent QA on project teams, management meetings, and other internal forums
Review and submit supplements, drug master files, plant/site master files, licenses, registrations, labeling and other chemistry-related submissions to the Federal Food and Drug Administration (FDA), appropriate state authorities, and to foreign regulatory authorities for Catalent and customers’ products as required
Assist customers in preparing accurate submissions and responses to the FDA and foreign regulatory authorities as these pertain to the chemistry and manufacture of products manufactured by Catalent-Somerset
Compile documents and construct Annual Product Reviews for commercial products manufactured at the Somerset site as requested
Participate in customer project meetings, customer complaint meetings, and PR meetings as required
Provide timely and accurate reports and assessments of problems or potential problems to the Director, QA
Maintain responsibility for interpretation and implementation of CGMP’s and other FDA regulations and pronouncements
Provide staff members with leadership, guidance, mentoring, coaching, and feedback against performance and development objectives
Assign project assignments to staff members with appropriate due dates for project completion
Ensure that departmental goals and project timelines are being met by the team
Provide training of personnel as required
Compile data for and participate in Management Quality Review Meetings for the site
Comply with Health, Safety and Environmental responsibilities for the position
Minimum of ten (10) years of experience working in QA/RA areas in the pharmaceutical industry with progressive management responsibilities
Compliance in an auditing capacity
Some regulatory knowledge is required
One to three years of experience in compliance, auditing, and data review
Full understanding of FDA and EU CGMPs and DEA regulations pertaining to clinical trial and commercial activities
Good understanding of statistics and audit techniques
Good communication skills both written and oral are a must
Must be well organized and have the ability to multitask
Thorough knowledge of CGMPS, ability to evaluate facilities records, processes, procedures and practices for conformance to these requirements
Good mathematics skills
Good Computer skills, including in depth knowledge of MS Office software package
Read and understand MSDS requirements and restrictions
Understand procedures related to Document Control, Quality Assurance and this job function
Requires a good understanding of drug manufacturing and laboratory operations
Experience with performing CGMP audits
Candidate must have the ability to work effectively under high pressure with multiple deadlines
Candidate must be detail oriented with good oral and written communication skills and good interpersonal skills
Candidate must have computer skills with a working knowledge with MS Office applications and other software databases
Candidate should be a creative thinker with sound business judgment and good negotiation and reasoning skills

Regulatory Manager Asia Pacific Resume Examples & Samples

Take active role to build regulatory intelligence for Process Solution. Focused area include Single Use as top priority, and will also cover Aseptic Processing, Virus Validation and process materials
Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Process Solutions interests
Safeguard Process Solution strategic interests and objectives in arising guidance, standards and regulation
Monitor and report on changes of relevant regulatory and compliance environment with impact with Process Solution business. Analyze available regulatory and compliance information
Increases the influence of Merck in important regulatory bodies and industry associations
Actively participates and represents Merck Life Science - Process Solution in relevant industry associations
Effective coordination of strategic activities of Process Solution subject matter experts in local regulatory bodies and industry associations
Secure flow of information from/to authorities, industry associations and Process Solution organization
Builds and keeps personal relationships to local and national authorities
Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines, regulations and standards
Training for and support of internal stakeholders, external customers and relevant regulatory bodies
Provide relevant training to educate local Process Solution marketing/sales colleagues about new regulatory trends and developments that drive our value proposition
Builds processes for the flow of information and regulatory intelligence within Process Solution organization APAC
Definition of processes to implement upcoming regulatory needs and requirements
Support regulatory expertise and consultation for customer regulatory inquiries
Closely work with global regulatory surveillance & advocacy team and Process Solution regulatory subject matter experts to link the local advocacy activities with global advocacy activities
Monitor competitor approach regarding regulatory requirements
Minimum of 5 years of relevant industry experience and/or regulatory affairs related to biopharmaceutical products, pharmaceutical substances and process materials
Knowledgeable of CFDA drug regulations and regulatory landscape of other important country/regions (eg. China, Japan, South Korea, EU, US)
Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, aseptic processing and validation procedures
Knowledge of regulations for Advanced Therapeutic Medicinal Products (cell, gene therapy)
Knowledge/experience for regulations concerning complex biologics (i.e., monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture
Experience working in a global, matrix environment
Ability to train and educate others
Effective management by influence
Some experience in thought leadership
Ability to work in multi-cultural teams
Good listening skills with the ability to analyze and respond to given situations quickly and effectively
Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels
Ability to indirectly influence other organizations and cultures
Proficient in MS Office Software (Word, Excel, PowerPoint, Project)

Regulatory Manager Resume Examples & Samples

Process and maintain FDA establishment registrations, FDA device listings, FDA Certificate to Foreign Government, FDA Exportability Certificates, Free Sale Certificates, US state licenses, foreign establishment licenses, global GMP certificates, and other regulatory certificates and licenses.Stacey note: should the OUS role be different in that perhaps it should mention other regulatory standards (For exame CE)
Process and distribute regulatory documents with notary, legalization, and/or apostille
Proofread, assemble, route, and archive regulatory registration files, as directed
Maintain schedule for renewal of regulatory certificates and licenses
Process and maintain regulatory quotes, invoices, and other budgetary items
Process and maintain requests to complete distributor letters for: distribution agreements, power of attorney, authorizations to register, product lists, market history, etc
Process requests and shipments of evaluation units and samples for product registrations
Maintain published regulatory records and databases in SharePoint and company document control system (Agile PLM) to ensure latest regulatory approved revisions are presented
Support operations, marketing, and sales with global market approvals for product shipments
Prepare and maintain general regulatory work instructions as directed
Support scheduling and arrangements for regulatory meetings
Maintain regulatory library of standards, guidance documents, and regulations
Route and/or retrieve regulatory submission records in company document control system (Agile PLM), as directed
Perform general typing, data entry, filing, faxing, printing and copying regulatory submission documents, as needed
Process and distribute Regulatory Affairs incoming and outgoing mail or shipments
Maintain office supplies for regulatory submissions
Support Regulatory Affairs team with day-to-day projects, as needed
Perform other duties or special projects as assigned
Two or more years of experience in quality and regulatory compliance related activities
Proficient in Microsoft Office Suite, in particular Outlook, Word, Excel, and PowerPoint
Proficient in document and asset management systems
Excellent prioritizing, organizational and interpersonal skills
Excellent documentation skills including record maintenance/ tracking and understanding of document traceability
Willingness to accommodate a flexible working schedule, across many time zones, that may involve evening and weekend working hours depending on project requirements
Ability to work in a fast-paced environment, with multiple tasks/projects
A detailed-oriented individual with a “can do” attitude and ability to work in a team environment as well as individually with minimal supervision
Self-motivated and disciplined
Demonstrated ability to work in a matrix environment with non-local and local leadership
Excellent English verbal and written communication skills
Working proficiency in French or German preferred
Able to travel up to 10% of the time, including international travel, as needed to liaise with our Corporate Regulatory team, our international offices and our regulatory agents/partners
3-5 years of related work experience
Proficient in document control systems, such as Microsoft SharePoint and Oracle Agile PLM
Proficient in data analysis, business intelligence, project management programs
Prior experience working with international organizations
Prior experience working with legal counsel or regulatory body agencies
Prior experience working within a medical device company
Prior experience working with operations and/or marketing teams

Global Program Regulatory Manager Resume Examples & Samples

Serves as regulatory representative to early clinical development and research project teams and to government regulatory agencies
Provides strategic regulatory direction to teams on submission strategy, interaction and negotiation with regulatory agencies. Serves as a regulatory liaison on the project team throughout early development
Provides advice to teams on several aspects of drug development based on appropriate regulations and their interpretation
Ensures that pre-clinical and clinical trial designs meet regulatory requirements
Supports the successful completion of major programs and may function in a project leadership regulatory role
For projects assigned as DRA Lead, lead the development of submission of clinical trial applications world-wide, progress reports, amendments, and/or periodic experience reports. Provides regional regulatory expertise (strategic and operational) to other DRA Leads
Ensures rapid and timely approval of clinical trial applications
May interact and negotiate with regulatory agency personnel in order to expedite approval of pending applications and answers any questions
Coordinates, reviews, and may prepare reports for submission. Coordinates and maintains reporting schedules for assigned compounds
Participates in one or all of the following activities: early development plan, regulatory strategy, risk management, implementation plan, and chemistry manufacturing control (CMC)
Develops technical solutions to complex problems which require the regular use of ingenuity and creativity
Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective for desired results
May represent organization as prime technical contact on contracts and projects. May interact with senior external personnel on significant technical matters often requiring coordination between organizations
Effective matrix management of interfaces with DRA staff, DRA operational staff, CMC regulatory and external collaborations
3-4 years of regulatory experience, preferably with a strong knowledge of US regulatory affairs. Additional knowledge of other regions is an asset
Oncology background highly preferred
Additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline is an asset
Involvement in an IND/CTA submissions and approval
Experience with HA negotiations
Innovation and strategy
Experience working in matrix environment or cross-functional teams
Strong interpersonal, communication, negotiation and problem solving skills

BB&T Securities Regulatory Manager Resume Examples & Samples

Coordinate with Corporate Compliance in the updating of firm’s WSPs as needed
Work collaboratively with the branch system on all aspects of the supervision function related to BB&T Securities
Update retail and institutional department procedures as needed
Ensure proper licensure and registration of retail and institutional associates and branch offices
Ensure traders follow the firm’s policies with regards to markups/markdowns by monitoring daily trading activity
Ensure all retail and institutional branch and home office associates follow policies regarding personal trading, outside accounts, political contributions, outside business activities and outside investments
May serve as a liaison between the firm and external auditors and Self-Regulatory Organizations
Oversee business recovery plans for Capital Markets, Private Client Group and Sterling Advisors
Chair the Regulatory Committee to determine the impact new rules and regulations have on the firm, provide the opportunity for the firm to comment on a proposed rule and build awareness of new regulations to those that will be most affected
Oversee regulatory governance with Financial Industry Regulatory Authority (FINRA), Municipal Securities Rulemaking Board (MSRB), Securities & Exchange Commission (SEC), Federal Reserve Bank (FRB), and other relevant governmental agencies
Oversee and perform outside account reviews
Collect employee trade pre-approvals and review employee and employee-related trading in the Protegent system
Manage Compliance with the U.S. Department of Labor Conflict of Interest Rule requirements
Seven years of financial services industry experience
Excellent analytical, problem-solving, organizational, and communication skills
Ability to effectively communicate with senior management utilizing written and verbal communication skills
Hold required FINRA Securities licenses (or able to be obtained within one year): 7, 8 (or 9/10), 24, 53, and 63 (or 66)
Ability to manage confidential material competently
Ability to travel, occasionally overnight, to industry conferences or for other business reasons
Good interpersonal, negotiating and problem-solving skills
Master of Business Administration (MBA) or other related graduate degree

Accreditation & Regulatory Manager Resume Examples & Samples

Technical support for regulatory, accreditation and contractual(payer) compliance, including coordination of Joint Commission
Compile high level Joint Commission readiness reports on a monthly basis for the purpose of senior level reporting
Reviews Policy and Procedures to assure regulatory compliance
Responsible for coordination of accreditation committee, including assignment of Joint Commission readiness for each team
Staff various standing committees such as policy development and regulatory compliance, to assure support, discussion, documentation,
Liaison to the Medical Staff Department, Medical Records Department, and other various departments to assure ongoing regulatory compliance
Performs other related duties as assigned or directed
Knowledge of regulatory, licensing and accreditation requirements
Knowledge of organizational learning methods
Knowledge of group facilitation techniques
Proven written and oral communication skills
Computer use skills to include: word processing, reports, statistics, graphs using various tools, e.g. Excel, Access, etc
At least 3 years experience with accreditation and licensing survey preparation and implementation in a healthcare setting, as guided by Joint Commission, CMS, payer requirements and metrics

Eemea Hub Technical Regulatory Manager Resume Examples & Samples

Act as primary technical regulatory (CMC) point of contact for the Affiliate DRAs and work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network
In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Eastern Europe, Middle East and Africa (EEMEA) markets associated to CMC changes originating at Roche/CMO manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities
Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility
Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert)
Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility

Safety & Regulatory Manager Resume Examples & Samples

10+ years’ experience working in a logistics or manufacturing environment
5+ years’ experience in a Safety / Regulatory role in a logistics or manufacturing environment, including internal and external audits
Bachelor’s Degree in a technical discipline (e.g. Chemistry, Chemical Engineering, Biology) or Operations Management / Supply Chain Management
Previous experience with personal safety and behavior-based safety programs
Experience with hazardous materials (e.g. ethanol used in hand sanitizers) and process safety management
Previous experience working in a TPM environment
3+ years’ experience in cross-functional project or program management
Certification as a Safety Professional

QA & Regulatory Manager Resume Examples & Samples

Develop and maintain the Quality Management system for the Healthcare sites in Duluth and Beaverton and ensure compliance to the medical device quality standards (ISO13485, FDA CFR Part 820, …)
Master’s degree in a technical field or an equivalent combination of experience and education
Proven experience in quality management(QMS) for medical devices with an absolute minimum of 5 years in a leadership role
Qualified auditor for ISO 13485 and FDA QSR
Excellent knowledge about active Medical Device QMS requirements for (MDD, FDA CFR part 820, Canada Health, …)
Excellent knowledge on FDA recall and reporting obligations
Excellent leadership and teamwork; demonstrated ability to motivate others, work as a team and take ownership where required
Good analytical skills to identify trends from different data sets
Willingness to perform limited travel per year (short travel)
Knowledge of business principles and basic financial analysis
Knowledge of SAP or similar ERP systems and basic knowledge of Business Intelligence Reporting

Financial Services Risk & Regulatory Manager Resume Examples & Samples

Development of solutions related to strategy, operations and management in a number of functional areas of corporations or start up companies
Corporate compliance, including developing, analyzing and assessing corporate compliance programs; constructing, monitoring and auditing programs; managing internal risk assessment and investigations, collaborating with organization management to integrate compliance controls into the scope of existing business practices; developing and delivering compliance training, and managing incident management systems
Management of multiple, complex projects and direct medium to large staff teams
Communicating with external clients and internal staff in an organized and knowledgeable manner
Leveraging project management and project facilitation skills, especially with leading and facilitating teams and developing client proposals
Identifying and addressing client needs: building, maintaining, and utilizing networks of client relationships and community involvement; communicating value propositions; managing resource requirements, project workflow, budgets, billing and collections; and preparing and/or coordinating complex written and verbal materials
Developing risk management programs, including risk monitoring and reporting, risk assessment and prioritization, and the facilitation of the definition of an organization's risk appetite and risk tolerance in alignment with their organization's strategy

Regulatory Manager Resume Examples & Samples

Communication with HA and follow up registration review and testing process to obtain the approval duly
Provide regulatory strategy to business partner to support new project development and existing product continuity
Work with regional franchise team on regulatory strategy development, provide innovative regulatory solutions
Monitoring external regulatory environment, shape business opportunities and challenges
Well manage registration and regulatory database, timely update and maintain document in a good manner
Other harmonization work in RA department

CMC Regulatory Manager Resume Examples & Samples

Supports and leads the preparation of CMC information for submission to global regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans
Global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions
Accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of commercial products
Creates and contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the portfolio at large
Leads document management and information management teams, within Global CMC / groups outside Global CMC
Serves as a Global CMC strategist for projects within product portfolios, providing regulatory assessments and developing regulatory strategies
Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation
Responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control
Ability to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the pharmatherapeutic portfolio. Manages the resolution of regulatory CMC/information management issues with project/program stakeholders
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate
Collaborates across Global CMC and functional activities in a matrix environment, with globally located cross-functional project teams including representatives from World Wide Pharmaceutical Sciences / Worldwide R&D / or Global Supply. Teams may include PSPTs, Co-Dev Teams and Manufacturing Lifecycle Teams
Interactions with regulatory agencies and/or external partners maybe required (either directly or in conjunction with Regulatory Affairs Department). May participate in pharmaceutical industry initiatives and support the development of positions to external regulatory policies
Degree in Science or similar
Experience in regulatory CMC is essential
Expertise in pharmaceutical science development or biopharmaceutical manufacturing and/or specific regulatory domain
Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects
Strong knowledge of pharmaceutical sciences, the pharmaceutical industry, and a clear understanding of drug development/commercial manufacturing of pharmaceutical products

Safety / Regulatory Manager Resume Examples & Samples

Take the lead role in running the Fair Lawn safety program, inspiring a culture where employees take ownership for safety. Engage employees in safety initiatives to eliminate or control safety hazards and reduce risk of injury or chemical release
Implement a comprehensive EHS inspection program and track corrective action items to completion
Ensure proper safety training for existing and new personnel
Conduct incident investigation and root cause analysis. Ensure injury and illness cases are effectively managed to closure
Manage the site Emergency Plan and Emergency Response Team. Provide or make arrangements for First Aid, CPR/AED and HAZWOPER training
Interface with other Regulatory Support personnel such as the Process Safety Engineer to ensure all aspects of site safety are addressed in Fair Lawn
Lead in ensuring compliance with HazMat (DOT, IMDG, IATA) regulations and practices by Fair Lawn and Bridgewater personnel
Periodically audit areas for compliance, developing action items to improve compliance in a continuous improvement effort
Provide interface for auditing/inspection government agencies, corporate inspectors and customer auditors
Provide technical/regulatory EHS guidance for chemical handling, ergonomics, lockout/tagout and other EHS programs
Provide other regulatory support as needed
IND-LPG

Regulatory Manager, Personal Care Resume Examples & Samples

Manage the provision and interpretation of regulatory information to both internal and external customers
Provide guidance and direction for responding to regulatory developments
Manage and maintain relationships with key industry trade bodies, industry consortia and regulatory agency officials
Maintain expertise in relevant EU regulations on personal care and a good working knowledge for other regions to ensure delivery of a high standard of service

Regulatory Manager Resume Examples & Samples

Experience in building global regulatory strategy/teams
Ability to adapt regulatory knowledge/experience to the Agilent environment and develop solutions that are appropriate for Agilent
Active listener that approaches challenges with an open mind

Real Estate Regulatory Manager Resume Examples & Samples

Bachelor’s degree and a minimum of 5 years experience in the wireless telecommunications industry in positions of increasing scope and responsibility
Strong knowledge of wireless industry including real estate, construction, transport, operations, and RF/System Performance functions
Strong leadership and organizational skills and the ability to develop, manage and track the execution of multiple projects simultaneously
Demonstrated ability to lead, motivate and coach large diverse teams toward common goals and objectives
Must have demonstrated ability to deliver quality results and to meet or exceed objectives while working in a fast paced environment
Excellent written and verbal communication skills. Responsible for communicating effectively at all levels
Excellent project management skills and a demonstrated ability to deliver upon commitments, goals and objectives
Proficient in Microsoft Office Suite (PowerPoint, Excel, Word)
Strong conflict resolution and negotiating skills
Highly autonomous

Flavor Regulatory Manager Resume Examples & Samples

Manage flavor information, including maintaining current flavor-related database information
Assess regulatory compliance of flavor materials and related consumer product and labeling issues
Act as regulatory expert and consultant in flavors and related areas, with internal and external partners
Establish, communicate, and enforce policies regarding flavor regulatory issues
Develop and maintain relationships with internal and external partners
Work with internal and external partners on flavor regulatory and policy issues
Create flavor training modules and train internal and external stakeholders
Knowledge of the regulatory approach to assessing the appropriateness of flavors (regulatory position, 3-5 years)
A foundation of scientific training sufficient to support scientific and regulatory flavor evaluation efforts and discussions (4-year science degree or Masters)
Knowledge of the flavor industry and experience in dealing with flavor suppliers on confidential regulatory matters (3-5 years)
Intense attention to detail is a must
Ability to recognize and address regulatory and trade secret issues that arise in casual exposure or in the course of research work
Ability to gather and manage detailed, sensitive information relating to regulatory status of flavor materials in various countries
Ability to gather and manage flavor regulations from various countries
Ability to interpret regulatory information so that it can be readily used in decision making
Must be conversant with global regulatory climate, including major markets, and comfortable in identifying and assessing regulatory situations in all markets
Ability to reduce volumes of information to a cogent position or recommendation
Sufficient computer knowledge to use formula system, and spreadsheet/database software to capture, manage, condense, and retrieve regulatory information

Junior Global Program Regulatory Manager Resume Examples & Samples

Serves as DRA representative on product sub-teams as needed
Contributes to preparation and finalization of Briefing Books
Coordinates responses to HA requests
Assists with the preparation, Quality Control, and submission of original worldwide dossiers and maintenance submissions
May ensure the timely availability of supporting documents (e.g., GMP certifications, registration samples etc.)
Coordinates regulatory activities and submits CTAs and INDs with Global Program Regulatory Director or Global Program Regulatory Manager supervision
Acts as main liaison with DRA Operations to ensure accurate and timely submissions to HAs
Prepare Annual Reports and renewals and ensure on-time submission to HAs
Enter product specific attributes as provided by DRA GPT representative into compliance database
Support regulatory compliance activities for projects and keep records of all major HA interactions in the validated document management system
Provide support as needed for non-project related regional excellence activities

Global Program Regulatory Manager Resume Examples & Samples

Experience with regulatory submission and approval processes in one or more major regions
Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry
Experience in HA negotiations
Min. 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas
Understanding of post-marketing/brand optimization strategies and commercial awareness preferred
Involvement in an dossier submissions and approvals
HA negotiations
Drug regulatory submission and commercialization in region
Analysis and interpretation efficacy and safety data
Basic organizational awareness (e.g., interrelationship of departments, business priorities)

Product Stewardship & Regulatory Manager Resume Examples & Samples

Prepare and/or oversee compilation of regulatory dossier submissions to EU and other EMEA Animal Feed authorities, in conjunction with global product stewardship & regulatory staff
Manage EMEA regulatory compliance for IB products touching the animal feed industry, in conjunction with global regulatory & product management staff supporting animal nutrition and grain/feed processing industries
Define approaches and procedures on new assignments and provide guidance to other staff
Translate goals of the company into a strategic plan for his/her areas of regulatory responsibility
Responsible for communication of regulatory strategies and policies, and implementation
Influence regulatory/product stewardship policy externally with trade associations (FEFANA, Amfep) and authorities (EFSA, EU Commission, country regulators)
LI-CW1
In depth knowledge and recognized for leadership & innovation in managing animal feed regulatory or similar program
Successfully impacted product introductions by providing regulatory guidance and/or successfully influenced decisions at plants to implement change
Successfully implemented complex/controversial regulatory policies and strategies, and systems to improve data communication
8-12 years of experience desired

Private Brands Regulatory Manager Resume Examples & Samples

Ensures that all product labels developed for the Supervalu Private Brands group are legally compliant for ingredient listing statements, nutritional content, marketing terminology, and provides recommendations for compliance options
Conducts regulatory research and provides support to ensure products meet regulatory requirements, including implementation of new label regulatory requirements
Assess and grade manufacturing partner regulatory resources; develop streamline regulatory compliance model that minimizes risk
Partners with regulatory agencies, product suppliers, Supervalu internal resources and regulatory industry professionals to stay current on regulatory issues with food and non-food products
Makes pro-active recommendations for Private Brand items with reference to pending regulatory requirements (state and federal)
Ensure Prop 65 compliance for Private Brand products sold in California
Reacts to regulatory non-compliance issues; working with internal and external partners to amend the compliance issue

Regulatory Manager Eame Resume Examples & Samples

Develop and implement robust regulatory strategies to support L&G-related portfolio of assigned active substances and products in EAME through
Scientific background in one of the disciplines relevant for regulatory
Good understanding of regulatory and political processes in the EU and in EU MS
Knowledge of relevant regional regulations and legislation specific to Lawn&Garden, including adjacent legislation
Effective team worker and good communicator
Negotiation and advocacy skills
Planning, project management and issue management skills
Delivery of quality work, even under time pressure
Curiosity, openness and willingness to challenge the accepted ways of working and to implement new ones
Coaching and development of team members
Fluent in English in technical discussions and advocacy

Regulatory Manager Resume Examples & Samples

Achieve, extend and maintain license to sell (registrations) for Syngenta products in AME (Africa/Middle East)
Provide regulatory expertise to the business
Plan and execute regulatory activities in AME and find innovative registration approaches within the legal regulatory framework
Manage all registration activities for a set of countries in the territory. This includes the preparation of registration submissions; answering requests from authorities; covering regulatory aspects of product labelling and formulation/source changes; keeping Syngenta internal registration databases up to date
Provide regulatory expertise and foresight to the business. Keep regulatory and business informed on regulatory changes and emerging issues which require proactive management
Provide annual plans, timelines and budget needs for all registration activities in-line with portfolio strategy/priorities. Track, review and report registration progress against targets
Establish a network with regulatory authorities, represent company interests and shape the local regulatory environment. Maintain close contact to local partners in order to grow and maintain expertise of national registration processes and legislations
Proactively manage product related issues, stewardship activities
Support supply chain on regulatory matters (shelf-life extensions, country of origin issues, review of inspection certificates, etc.)
Cover regulatory aspects and the coordination of the internal PS&RA governance process
Degree in Science or relevant technical qualification
Good knowledge of regulatory requirements in the crop protection industry; gained through direct experience in a regulatory role; or through significant technical experience
Demonstrated strengths in communication, self-organization and problem solving and developed negotiation/influencing skills across different cultures
Excellent team working, project management and interpersonal skills
Sufficient regulatory experience to be able to work autonomously
Attention to details and ability to complete and deliver tasks on time
Show ability to work accurately and to deliver dossiers/special tasks on time and up to Syngenta standards
Good communication in English, French would be a plus

Regulatory Manager Resume Examples & Samples

Supports the local study team in preparation of trial documents for regulatory submission
Submits CTA and any other documents required regulatory submission to the local Regulatory Authority
Follows up the regulatory approval progress and ensures that submissions are performed in a timely manner, follow import/export licenses obtaining (if applicable)
Ensures that the trial documents provided to the application for regulatory approval and obtaining of regulatory approval for clinical trials are carried out in accordance with local rules and regulations, and that product information given to Regulatory Authorities is the most recent and updated
Acts as liaison with local Regulatory Authority
Maintains a file of country specific regulations, requirements, procedures, and etc., which are relevant to clinical trials and informs GCO Ukraine employees on any changes in a timely manner. Provides Local Trial Manager with trial-specific correspondence with Local Regulatory Authorities
Represents the company and the organization adequately to the customers and other external parties
Conducts business in line with the HCC, company policies and procedures, including applicable SOPs, always having the ethical aspect in mind
Maintains adequate communication with relevant parties within and outside the company
Complies with ICH-GCP and all applicable local laws and regulations
Actively follows trainings to ensure adequate qualification for performing job-related tasks
Reports (suspicion of) fraud or scientific/ethical misconduct as appropriate
Regularly updates information in applicable systems and templates
Contributes to the development and improvement of departmental procedures and processes and templates in the scope of the company’s effort towards continuous quality improvement
Maintains quality standards and timelines that are consistent with business needs
Minimum of 3 years’ experience in the pharmaceutical industry, at a CRO including extensive clinical research experience
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment
Strong interpersonal and negotiating skills, exelent communication skills
Strong knowledge of MS Office.Clinical Data Management

Legal / Regulatory Manager Resume Examples & Samples

Provide oversight for Legal / regulatory requirements for CTI EMEA and CIS entities
Act as a key CTI point of contact for all legal/regulatory items
Support Risk and Controls team in disseminating regulatory updates to CTI EMEA and CIS entities and assessing the impact of these regulatory changes for entities/countries within the region together with Risk Managers
Key CTI point of contact for the external / regulatory audits for CTI EMEA teams to ensure no surprise findings or finding due to lack of communication or management of the audit requests. Liaises with external and regulatory auditors when appropriate
Oversight CTI EMEA and CIS entities for the governance of legal and regulatory requirements including, but not limited to, Cross-border, Data Privacy and SOX programs
Maintains a professional oversight of issue remediation activity for entities within the assigned area
Works collaboratively with the CTI EMEA and CIS Risk and Control Department to develop and execute the strategy for legal and regulatory requirements. This includes driving our supported teams across CTI towards an External Audit Ready/ Regulator Ready state, where processes and key risks are well understood and controls to manage risks are fully implemented and measured
Manages oversight of the effective disclosure, recognition and subsequent closure of control issues within the entities supported
Attend operational management meetings as required for the entities supported
Design and develop controls for CTI relevant legal/regulatory requirements to ensure that CTI EMEA and CIS functional entities are meeting strategic goals
When required engage with global teams and risk management teams on key control issues
Continually seek to leverage process improvement opportunities
Work with the various Global and Regional Risk and Control heads to ensure a robust operational risk framework is embedded for all the represented functions in the Budapest Centre
Provide input to the CTI EMEA and CIS Risk and Control Management Meeting in legal/regulatory updates, issues on an ad hoc basis
Understanding of Controls environment, Risk based thinking and Information security principles
Process definition and creation, including document control
External/regulatory Audit and/or risk management experience is essential
Ability to plan, organize, monitor workload and priorities across multiple groups
Understanding the legal / regulatory compliance processes
Proficiency with all MS Office products
Excellent interpersonal and written skills
Contributor with strong drive and self-starter attitude
Strong work ethic and excellent use of discretion and judgment
Analytical approach with an eye for detail and emphasis on accuracy
Act with urgency , courage and conviction
Be accountable – own the outcome
Act with integrity – do what is right
Strong organizational ability
Proven leadership skills
Ability to build strong relationships between businesses and across countries
Excellent level of written and spoken English
Experience of the reporting and analysis at a project / senior management level
Professional IT or Risk qualification. CISA , CISM and/or CRISC [Preferred]
Relevant leadership or project management/operational experience

Quality / Regulatory Manager Resume Examples & Samples

Performs the day to day audit and quality assurance functions within the training center
Performs all scheduled quality monitoring activities (including internal audits, management evaluations, inspections, supplier audits, etc.,)
Establishes (through quality monitoring), performs follow-up and ensure closure of corrective and or preventive actions
Implements Continuous Improvement activities under the guidance of the Accountable Manager and other responsible managers
Ensures that the system monitors the processes put in place to ensure regulatory compliance and to inform the Accountable Manager of its performance and all necessary remedial actions
Identifies and records any concern or findings and the evidence necessary to substantiate such concerns or findings
Follow up internal audit corrective and or preventive actions, verifying the satisfactory implementation of solutions within the specified time frame
Implements, monitors and coordinates improvements to the Quality and Regulatory System
Verification by monitoring the activity in the fields of training device qualification and training, that the standards required by the authorities are being carried out under the supervision of the relevant manager
Ensuring that the quality assurance program is properly established, implemented and
Managing the operation of the quality system
Organizing, executing and reporting the Quality Monitoring Program to verify that standards and rules are complied with
Monitoring, following up and evaluating the implementation of corrective actions that may arise from quality inspections, audits and management evaluations
Provide management with an independent assessment of corrective and preventive actions, their implementation and completion
Maintaining records of completed audits, non-conformities and corrective and preventive
Edition, amendment, distribution and updating of the quality documents
The implementation and monitoring of the quality system
Programming, supervising and recording the conduct of Quality Audits to verify that standards and rules are complied with
Coordinating improvements to the quality system
The overall function of the Quality Manual
Ensuring that follow-up action within an agreed time frame is taken in respect of any non- compliance
Maintains records of completed audits, non-conformances and corrective and preventive actions
Performs annual Quality and Regulatory updates briefing to the personnel of the training center
Maintains all reports and records related to the Quality procedures to provide evidence of the effective operations of the QMS at the center
Planning and coordinating of annual instructor assessments and organization of standardization meetings in collaboration with the Head of Training
Liaise with External Auditors
Liaison on Quality and Regulatory matters concerning the Quality and Regulatory plan
Liaison with Head of Training and Instructors to prepare and publish training plan for the Training Group
Responsible for inputting amendments to the manuals
Keep informed about the Philippine Civil Aviation Regulations and any changes thereto as well as the internal policies of CAE in relation to operating an Aviation Training Organization, Pilot Licensing and Simulator certification among other matters and ensure compliance
As part of Regulatory oversight, handle all Environment, Health & Safety related matters and ensure compliance with the PCAR and relevant CAE internal policies
Be the designated SMS Manager
Other duties that may be assigned

Quality & Regulatory Manager Resume Examples & Samples

Work with global and local Quality network members to deploy an effective internal and external audit programme and maintain those processes and systems necessary to maintain our ISO9001 certification
Liaise with BSi regarding the external certification audit of our activities and the coordination of improvement actions associated with audit findings
Work with global and local regulatory network members to deploy an effective vigilance programme for IVD products and reagents ensuring compliance with internal quality regulations and the In-vitro Medical Device Directive
Liaise with the Medicines and Healthcare Regulatory Authority regarding the management of in-field vigilance actions including field safety corrective actions and reagent recalls
Work with Managed pathology development teams to ensure compliance of customer oriented managed pathology service solutions with ISB0129 and the In-vitro Medical Device directive
Work with other Local Quality and Technology team members to raise the awareness and engagement of staff in the Healthineers Principle, ‘No Compromise on Quality&#8217
Essential: Detailed understanding of ISO9001 and a track record in implementing and managing an ISO9001 certified management system in a medical device environment
Essential: Understanding of those elements of the IVDD that apply to the operations of an in-vitro diagnostic device sales and service provider
Essential: Understanding of those elements of the MDD that apply to the operations of an in-vivo medical device sales and service provider
Essential: Understanding of product safety principles and the operation of I-Field Medical Device Vigilence systems
Useful: experience in operating customer complaint and Corrective And Preventative Action, CAPA systems
Useful: experience in liaison with regulatory authorities including the UK Medicines and Healthcare Regulatory Agency
Useful: knowledge of process improvement tools and techniques including the application of lean
Useful: knowledge of NHS ISB0129 Clinical Risk Management: Application in the Manufacture of Health IT Systems - Post Implementation Review
Useful: knowledge of the European Foundation Quality Management Model

Regulatory Manager Resume Examples & Samples

Achieve, extend and maintain license to sell (registrations) for Syngenta products in Zambia
Plan and execute regulatory activities in Zambia and find innovative registration approaches within the legal regulatory framework
Support all regulatory activities in Tanzania
Manage all registration activities for Zambia and provide support to Tanzania. This includes the preparation of registration submissions; answering requests from authorities; covering regulatory aspects of product labelling and formulation/source changes; keeping Syngenta internal registration databases up to date
Ensures, in coordination with and support from the technical lead, registration trial protocols are developed in a timely manner, registration trials are set up and followed continuously for assessment and report writing (if required)
Good knowledge of regulatory requirements in the crop protection industry for Zambiagained through direct experience in a regulatory role; or through significant technical experience
Good communication in English and local languages
Travels to Tanzania and other countries within territory if needed

Hazard Communication Regulatory Manager Resume Examples & Samples

Provide expertise to guide the business in finding solutions to hazard communication and chemical regulation compliance issues that affect our products, ingredients, and labels. Ensure information in Master Database related to hazard communication is accurate and current based on available information
Maintain a strong network of experts, government agencies, industry peers and other stakeholders needed to maintain a favorable regulatory environment for the company. Represent the company externally on relevant trade and scientific organizations
Influence, review and monitor new/changing global regulations so that leadership can be proactively informed of emerging hazard communication and chemical regulatory issues that are an impact to the business and identify strategies to address them. Interpret, assess business impact and implement new regulations as required
Partner with the business and internal manufacturing to identify needs to meet current and future requirement for hazard communication
Direct the activities of the team and provide leadership and motivation including coaching and mentoring team members
Experience in the fields of hazard communication, Safety Data Sheets, and transportation classifications, preferably with a flavor/fragrance, consumer product or chemical company
Working experience with hazard communication regulations
Communication Complexities
Judgment and Decision Making
Expert knowledge of Global Health and Safety regulations

Communication & Regulatory Manager Resume Examples & Samples

> Regulatory and Quality management
Establish and build relationships with key stakeholders internally and externally,
Implement global strategy of Regulatory and Quality functions on CBU level,
Successful implementation of global Regulatory and Quality projects,
> Nutrition Science and Public affairs
Cooperate with other functions providing them nutritional expertise,
Provide nutritional expertise in external relations,
Coordination of timely approvals and validation of communication and artworks in Baltics,
> Build functional capabilities and develop self & others
Develop and educate self and team,
> Core processes & routines
Communication and artwork validation,
Timely product notifications, registrations and reimbursements in Baltics,
Nutrition Science expertise in projects,
Crisis management & risk assessment,
Product notifications, registrations & reimbursement,
Complaint handling, Quality reporting,
Budget management of the area
Academic background, university degree in medical/ nutritional/ legal sciences as well as some significant experience in the field or related areas,
Ability to manage complexity,
Effective stakeholder management (networking & management)
Coaching and training skills,
Project management ability and medical credibility,
Strong ability to understand and identify opportunities,
Presentation skills and desire to develop oneself,
Achievement oriented, flexible, agile, personable and pragmatic,
Strong problem solving skills and self-motivated,
Able to deal independently with unexpected changes,
Team player with coaching and training skills,
Excellent languages skills: Latvian and English as well

Senior Technical Regulatory Manager Small Molecules Marketed Products Resume Examples & Samples

Provide strategic leadership and regulatory decision making for synthetic marketed products in cross-functional product team
Develop global Chemistry and Manufacturing Controls (CMC) regulatory strategy
Manage the generation of high quality regulatory submissions required for the filing of technical changes, renewals and clinical trial applications to health authorities globally
Interact with management from multiple internal functional areas, corporate partners, manufacturing sites and international affiliates
Facilitate the effective and rapid implementation of technical changes
Negotiate successfully with affiliates, partners and health authorities

Regulatory Manager Resume Examples & Samples

Responsible to ensure compliance with all Federal, State, County and Town Permits
Responsible for SPDES Compliance
Responsible for MPFL/CBS (Major Petroleum Facility License/Chemical Bulk Storage) Compliance
Responsible for Hazardous/Non Hazardous Waste storage. Disposal and record keeping
Responsible for OPA 90 Compliance (Oil Spill Response/Drills)
Responsible for site Emergency Plan and Environmental Compliance procedure review updates
Responsible to Administer Tuesday Morning Safety Brief and monthly Safety Committee meetings
Responsible to administer Contractor Safety requirements
Responsible for 33 CFR 105 (MARSEC Security Requirements)
Act as Site Facility Security Officer
Responsible for site NERC CIP Security Requirements
Responsible for the Operation of the site Waste Water Treatment Facility
Responsible for the Station Clerical staff
Must be available for immediate consultations by colleagues’ beyond normal work hours
On a rotating basis, acts as a Division Standby Supervisor who responds to after hours request for maintenance assistance
The incumbent will act as the company's spokesperson with regulatory agencies. As such, excellent interpersonal and managerial skills are required
The incumbent must have proven ability to act independently
Knowledge and a good working understanding is required in the areas of thermodynamics and fluid mechanics

Regulatory Manager, Food Resume Examples & Samples

Handle all US regulatory issues for (new and existing) food ingredients for Bakery, Processed Meat, Harvest Intervention, Dairy, Beverages and sugar Confectionary
Check US regulatory (FDA/USDA) compliance by regulatory audits
Project management of special regulatory projects
Company which empowers people and where your initiatives, and ideas make a real difference
International and truly diverse organization
Unique possibility to be trained by our internal expertise in the world of bio based products. We invest in relevant training courses related to your particular discipline
Engaged team of employees; we want you to be surrounded by happy colleagues who enjoy coming to work
Friendly, informal and supportive culture
Flexible, open and collaborative working environment

Quality & Regulatory Manager Resume Examples & Samples

Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management
Review and Approval of designated project documentation in product creation projects
Advise to product creation projects concerning the definition and implementation of quality assurance activities
Advise upper management with respect to release for delivery of products
Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments
Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals
Participation in and verification off changes to DMR and release orders where Q&R involvement is needed
Participates in the maintenance and improvement of the Quality Management System
Drive the execution of and/or support and advice the organization in corrective and preventive actions
Initiate, stimulate, support the implementation of process improvements

Regulatory Manager Resume Examples & Samples

Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience required; OR
Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 3 years' research study or other relevant experience
Supervisory or project management experience required
Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
Strong organization and interpersonal skills
Computer expertise include being literate in Microsoft Office, Internet and database use
Nursing degree, Master’s or other graduate level degree or the equivalent of education, training and experience from which comparable skills can be acquired
Lean/Six Sigma trained
Project Management or Program Development experience

Regulatory Manager Resume Examples & Samples

Formal Trading Standards qualification e.g DTS, DCATS, DCA or equivalent
Expert knowledge of legislation and best practice guidelines relating to fair trading, advertising, food composition and labelling
Knowledge of legal procedural legislation and guidance
Proven expertise liaising with regulators, government and independent bodies (including the Advertising Standards Authority)
Lead Assessor qualification beneficial
Significant leadership skills

Environmental & Regulatory Manager Resume Examples & Samples

Bachelor’s degree required. Degree in environmental, chemical, mechanical or process engineering preferred. Degrees in science or environmental studies considered with appropriate experience, skills and knowledge, such as an advanced degree in a pertinent discipline. Seven to ten years of experience required
Must have working knowledge of US Federal environmental regulations; international experience a plus
Knowledge of management systems such as ISO 14001, OSHAS 18001 or EPA’s CFEMS a plus
Must have experience conducting audits, inspections, and evaluations. Lead auditor experience a plus
Excellent project management and written and verbal communication skills
Consumer Goods industry and/or product development experience a plus
Requires 30-40% travel, including international
Must be adept in the use of the Microsoft Office suite

FTU Regulatory Manager Resume Examples & Samples

Education: Master’ Degree/CA/MBA
Experience: Candidates with1- 2 years of related work experience
Excellent interpersonal/communication skills and ability to develop strong partnerships with clients and other stakeholders
Experience of working with FEMA related processes
Sound understanding of Capital Markets in India and keeping abreast of emerging market developments
Ability to translate complex market requirements through clear and precise verbal and written communication
Ability to translate client requirements and work with internal operations team to achieve results to the satisfaction of clients
Ability to adapt to constant changing needs of the business
Postgraduate qualifications are necessary
Excellent MS Excel and PowerPoint skills are an added plus point

Global Regulatory Manager, Immuno Resume Examples & Samples

In conjunction with Regulatory Leads, coordinate creation and approval of global regulatory plans, and transmit to internal and external experts to execute the plan
Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time
Manage, track, review regulatory deliverables from external partners in line with vendor manager
Maintain regulatory work schedules with vendors and vendor managers for assigned project using common data-points and milestones
Coordinate GRS support for HA interactions lead by regional / local liaisons
Support Regulatory Lead is the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc)
Provide support for tracking progress and resolving issues with CTA preparations and submissions and approvals
Facilitate the regulatory dossier submissions to HA (IND, CTA, BLA, NDA, etc) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions
Coordinate preparation of response to HA questions according to a rapid response process for assigned projects
Maintain tracking data in PMC and PMR database
Coordinate regulatory communications required for regulatory actions to regional and local regulatory
Writing, reviewing signing and submission of maintenance regulatory documents for all IND/CTAs - All within group with consultation of the USL, EUL or GRTL as needed
Annual Reporting Responsibilities for regulatory owned components
Support submission of US BLA/NDA submissions, as assigned
Working knowledge of regulatory procedures (US or other) or in a specific therapeutic area (2-3 years)
Demonstrates a high-level of self-motivation and professional commitment. (In)direct management experience of people or major projects
Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary)
Ability to rapidly adapt to different issues and projects at one time. Good interpersonal skills
Comprehensive understanding of the pharmaceutical industry
Comfortable working in a fast-paced environment where speed is paramount
Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
Ability to recognize, articulate, and accept calculated risks to make informed decisions
Willingness and ability to effectively cooperate and partner with external vendors and BMS
Develop understanding of different TAs due to assignment to different projects
Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape
Increased exposure to global and multifunctional teams
Potential development into Global Strategy function, US Liaison or other role in Regulatory Sciences

CMC Regulatory Manager Resume Examples & Samples

Directly manage completion of multiple dossier components to meet project timelines
Review documents and dossier components to assure that technical/regulatory strategy and data integrity processes are followed
Accountable for ensuring that dossier components meet global/regional standards for content, quality, and regulatory requirements
Work closely with project team members and CMC regulatory team to produce high quality submissions
Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes. Effectively adjust plans to deal with changes and obstacles
Identify, document, and communicate regulatory project risks that could impact timeline and quality of regulatory submissions
Organize and archive CMC dossier components and supporting documents in appropriate document management systems
Interface with regulatory operations staff to coordinate dossier review, approval and publishing activities

Regulatory Manager Americas Resume Examples & Samples

Manages supervisors and manages enterprise regulatory associates located in the Americas region
Supports the management of distributor relationships in the regions
Requires proven skills in leading/managing the execution of processes, projects and tactics. Knowledge in product regulations required including WEEE, REACH, RoHS, equipment safety directives and similar

Regulatory Manager Resume Examples & Samples

Plan, provide strategic guidance, coordinate and manage the day-to-day CFDA pre-market approval submissions for Companion Diagnostics (CDx) Including type testing, registration files, instrument clinical evaluation report, IVD local concordance study,and obtain approval of premarket product registration timely
University degree in a technical discipline (bio-engineering, chemical, biology, laboratory diagnosis, pharmaceutical preferred)
A minimum of 6 years of RA experience in IVD or medical device field
Strong skills in regulatory strategy and planning, preferably within vitro diagnostics
Experience working directly with CFDA
Strong decision-making and leadership skills
Experience working in projects as part of project teams
Capability of working in multiple project teams in parallel and a sense-of-urgency in meeting deliverables and project requirements
Knowledge of pathology and/or oncology is preferred
Knowledge and experience in APAC region regulatory affairs is required

Regional Product Stewardship & Regulatory Manager Resume Examples & Samples

Implement our corporate standards across the business segments and manufacturing facilities in their region
Provide functional guidance to the Product Stewardship Coordinators of the business segments
Interact with functional groups in the region to ensure alignment on standardized processes
Understand and execute ACC’s Responsible Care Product Safety Code Requirements as part of Axalta’s global strategy to obtain and maintain RC 14001 certification
Be an active member of the Global Leadership Team for EHS&S and PS&R
Lead the Regional PS&R Network
Provide guidance to the appropriate functions on how new standards/legislation will impact our business operations and our overall strategy for PS&R
Responsible for the auditing schedule and process to confirm our performance and compliance against program metrics and goals, internal company requirements, and regulations in an effort to drive continual improvement
Develop leading and lagging indicators to track performance and understand trends to improve
Stay abreast of regional, social and regulatory trends and impending actions that may have an impact on company, products, process and markets and advise regional leadership
Provide key insights into corporate advocacy objectives and strategies
Lead efforts to identify and implement consistent best practices from the standpoint of effective and efficient tools, as well as standardized practices and processes
Report on established, key metrics to evaluate the program’s performance related to addressing product risks, program alignment with other business functions, regulatory and customer requirements
Ensure necessary information systems and tools are in place and maintained to meet requirements for Product and Global Chemical Data Management and Reporting
Responsible for investigating and reporting of Product Stewardship Incidents to identify and analyze root cause, as well as communicating to raise awareness
Effective change management skills and demonstrated ability to lead and inspire positive change within an organization
Highly proficient relationship management and networking skills
Proven ability to influence, negotiate, and resolve conflicts
Experience in working with cross-functional, multi-cultural, and virtual teams

Regulatory Manager Resume Examples & Samples

University Graduate in pharmacist or science, post graduate would be an advantage
English Language – written and spoken fluently
Bahasa Indonesia - written and spoken fluently
Must be able to communicate clearly and concisely in both languages
Min 5 years of experience in regulatory position with a reputed Consumer Health Company with working experience in managing registration for Cosmetics or Skincare products
Experiencing in changing regulatory environment i.e. proposing the change of regulatory system/regulation
Had been exposed to quality, production & R&D environment
Strong logical and technical skills
Mastering the Indonesia registration regulation and its related regulation
Having a good relationship with government official and associations
Bridging the external and internal requirement
Knowledgeable in quality system and product development system

Regulatory Manager Resume Examples & Samples

Develop and implement robust regulatory strategies to support portfolio of assigned active sub-stances and products in EAME
Provide high quality regulatory advice and foresight to wider EAME Regulatory and key stake-holders (e.g. business, development, global) to support the development of EAME portfolio strategy
Provide regulatory insights into competitor portfolios to wider EAME Regulatory and key stake-holders (e.g. business, development, global) to support the development of EAME portfolio strategy
Obtain and maintain EU approval of active substances in line with agreed portfolio objectives through
Good understanding of regulatory processes in the EU
Regulatory experience in the EU
Effective time and task management to ensure delivery of the business needs
Delivery of quality work even under time pressure
Ability to manage complex issues without being the expert in any one discipline
Openness and willingness to challenge the accepted ways of working and to implement new ones
Active management of the workload
Willingness to try new approaches

Regulatory Manager Resume Examples & Samples

Total package up to £72k (depending on experience)
Establishing the ‘missing market(s)’ for flexibility services in electricity
Participation in the related Ofgem Flexibility project
Electricity Balancing markets
Commercial opportunities for energy storage
Developing the roles and responsibilities of electricity network system operators (transmission, distribution), including their interfaces with the commercial market
An excellent understanding of power generation, wholesale electricity markets, decentralised energy and the policy framework within which commercial companies, relevant industry bodies and network companies operate
Regulatory experience in the power & electricity markets with high quality strategic, technical, economics or legal qualifications
Good understanding of the regulatory frameworks within which Centrica Group operates, and of the regulatory decision making processes
An proven ability to “horizon scan”: anticipating and keeping abreast of external developments that may influence the direction of electricity policy and / or create new business opportunities
Proven experience to develop innovative and powerful solutions to complex regulatory proposals driving value or avoiding cost
Ability to work flexibly, across a wide range of high profile and fast moving tactical and strategic issues
Strong leadership skills and a proven track record in influencing to deliver commercial value
Excellent verbal, presentation and reasoning skills
Ability to build constructive relationships at all levels of an organisation
Excellent analytical and conceptual thinking skills

CMC Regulatory Manager Resume Examples & Samples

BSc in life sciences or equivalent qualification/expeirence
CMC Regulatory Affairs or CMC development experience in Biopharmaceuticals or Cell & Gene Therapy gained with direct involvement in regulatory submission preparation
Experience of authoring or preparing and submitting CMC content for clinical trial applications and/or marketing applications
Strong verbal and written communication skills with good attention to detail
Capable of working and making decisions independently
Successful track record of delivering CMC strategies and submissions content that comply with global regulatory requirements
Excellent team working abilities and effective influencing skills
Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines
Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives
Represent Biopharmaceutical CMC Regulatory Affairs on regulatory networks and matrix teams, providing regulatory advice and guidance to product development teams and the global manufacturing organisation
Be responsible for the global CMC regulatory activities for projects teams, setting the strategy for CMC regulatory content of clinical trial applications and marketing applications
Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of Biopharmaceutical and/or Cell & Gene Therapy products
Support license maintenance, change control requests, and post-approval submissions, ensuring delivery to agreed timelines
Maintain high quality standards and a continuous improvement and innovative approach in responding to the evolving regulatory environment
Communicates across the company to influence CMC project and policy issues that are aligned with business needs
Based in Ware, Hertfordshire, UK this role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity

Regulatory Manager Resume Examples & Samples

Master of Science (M.Sc, field of food chemistry/biotechnology or similar) or a Master of Laws (LL.M.)
Min. 3 years functional technical experience within food regulation, mainly EU
Experience within production or Quality from European food industry or experience from Food Authorities
Knowledge of beer, cider and other beverages and their production
A team-player, who promotes collaborations across functions with colleagues and customers of diverse background and culture
Works independently, systematic and detailed with known as well as new subjects
Excellent at multitasking and prioritizing as appropriate
Ccredible and accountable and demonstrates commitment and personal ownership
Makes problems clear so that they can be tackled
Plans effectively, sets priorities and puts ideas into practice
Develops, shares and utilizes best practice
Preferable knowledge of web based applications (MS Sharepoint)

Regulatory Manager Resume Examples & Samples

In collaboration with Sandoz Development and Maintenance Centers, the RCC-Manager is accountable for the preparation and coordination of regulatory submissions for assigned countries, ensuring each molecule has a defined regulatory strategy and in full compliance with government regulations
In collaboration with Sandoz Licensing Regulatory Department and Country Organizations, is responsible for new product assessments and due-diligence activities with local and international partners
Responsible for analyzing the dossier for any gaps for predicted DLs from the authorities and to put the strategy for them (GAP Analysis)
Accountable for the timely approval and the regulatory launch readiness of Sandoz products in the territory
Monitor and evaluate changes in local and regional regulations for regulatory impact on development projects and ensures commercial feasibility of regulatory strategy
Manage internal and external regulatory inquires and response strategy for deficiency letters in close collaboration with country organizations
Participate in the development and implementation of local and regional regulatory strategy with Sandoz Development & Maintenance Centers and international partners. Acts as primary technical & regional expert for assigned countries and projects
Participate in local and regional meetings, lead and represent Sandoz in external meetings and conferences (as required)
Mentor and assist junior associates

Global Program Regulatory Manager Resume Examples & Samples

Responsible for implementing regulatory strategy and managing operational activities for assigned regions
Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions
Partners with regions to align on regulatory strategy in order to fullfill business objectives. - Implements RFP across assigned regions
Works with DRA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy
Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders
Works with DRA GPT representative and/or GTAL to interact with regulatory consultants/advisors for strategy input and challenge
Represents DRA on or leads sub-teams as required. HA Interactions
Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL
Interacts directly with HAs as appropriate in meetings with DRA GPT representative and/or GTAL
Coordinates and plans rehearsals for HA meetings
Facilitates preparation and finalization of briefing books
Develops and implements plans for timely response to HA requests and coordinates responses
May serve as local HA liaison depending on location (e.g., FDA or EMA)
Experience with regulatory submission and approval processes in 1 or more major regions
2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas
Regulatory operational expertise. - Strong interpersonal, communication, negotiation and problem solving skills. - Basic organizational awareness (e.g., interrelationship of departments, business priorities)

Financial Services Africa Banking Regulatory Manager Resume Examples & Samples

Manage the delivery of Advisory engagements
Assist in managing the financial aspects of engagements by organising staffing, tracking fees and communicating issues to project leaders
Build strong internal relationships within Financial Services Africa and across other services
Supporting and guiding clients to meet regulatory requirements for reporting and business standards
Reporting to clients and SARB
Client liaison, including leading meetings with clients and the SARB
Build strong and long term relationships with key client sponsors
Contribute to people initiatives including recruiting, retaining and training Financial Services Africa professionals
Develop personal profile and awareness of EY offerings in the marketplace
Manage risk of delivery on client engagements
Act as an ambassador of EY in the market and with clients
Thorough knowledge of banking regulatory reporting and related processes
Four years to eight years of relevant work experience preferred
Ability to understand and adapt to changing regulatory and legislative requirements
Extensive knowledge on
Track record with a blue chip risk consulting firm or large banking institution
Relevant postgraduate degree with strong academic record
Professional qualification such as CFA, FRM, PRM preferable

Regulatory Manager Resume Examples & Samples

BS degree in business or science discipline
5+ years’ recent team management within a business environment
EPA/FDA industry experience preferred with a functional knowledge working with regulated products
Must be able to interact effectively with internal and external customers to meet timelines
Attention to detail/documentation and excellent written and oral communication skills
Must be able to work in a multi-task environment
Proficient with MS Office Suite is required
Domestic travel estimated <10% or as business needs determines

Regulatory Manager Resume Examples & Samples

Monitor and participate in the stakeholder processes for the Electric Reliability Council of Texas and Southwest Power Pool. This will involve providing the trading and marketing groups with information about rule changes and other developments that will impact company positions or operations or the markets in which Shell Energy participates, advocating positions in these processes that will protect or advance the company's objectives and provide advice on potential market or operational outcomes
Follow developments before legislative bodies, state utility commissions (with focus on Texas PUC) the Federal Energy Regulatory Commission and other governmental agencies that may affect gas and power marketing and trading activities in the region and report on such developments to relevant groups within the company
Provide support for the company's marketing and trading activities, including tariff review, commenting n transactional documents and acting as a compliance resource relating to such activities
Manage participation in regulatory proceedings through the filing of pleadings or directing the activities of outside counsel
Represent the company in trade associations and work with such organizations or ad hoc advocacy groups before regulatory and governmental bodies to advance the company's objectives
Support the efforts of other professionals within the Regulatory Group and assist other Shell entities on relevant issues
Support the development of new commercial products, strategies, or efforts with interpretation and implementation of ISO/RTO policies
Maintain relationships with each RTO/ISO, and potentially commercial customers, to support various commercial needs, including, but not limited to, operation of congestion revenue rights/transmission congestion rights markets, energy markets, capacity markets, and policies pertaining to traditional grid-switchable resources
Act as liaison with customers, ISO/RTOs, NERC/PUC entities, and Shell commercial teams to verify compliance with regulations as they pertain to Shell
Manage and provide feedback and support to contract resources providing regulatory intelligence to Shell
Maintain a fundamental understanding of wholesale electric power markets

Regulatory Manager, North Asia Resume Examples & Samples

Bachelor degree or above in Chemistry, Applied chemistry or strong technical related background
Have in-depth knowledge of paints related industry
Has a proven track record of managing projects in cross-functional environment in multinational company
Experience in PSRA or HSE is required, Green label accreditation or business Regulatory Affair experience is preferred
Be skilled in English and be capable to interact with senior colleagues across the globe with ease
Has strong commercial sense to be able to interpret regulation requirement with Business team
Good communication skill and influencing skill

Global Payments Product Risk & Regulatory Manager Resume Examples & Samples

Deep Industry knowledge of Payment systems
Broad understanding of current regulatory environment
Analytical individual with ability to model data and draw conclusions
Graduate Degree, with distinguished academic achievement, high level of personal integrity, interest in banking as evidenced by related work experience, proven dedication to excellence, leadership qualities and a flexible, creative, innovative personality
Technological proficiency, Analytical and modeling proficiency, excellent excel, presentation and writing skills

Regulatory Manager, Americas Resume Examples & Samples

Develops, implements solutions to department and enterprise global issues and regulations
Bachelor's or Master's Degree preferably in engineering or scientific discipline or equivalent combination of education and experience
7+ years of relevant regulatory experience with 2+ years as a manager
Proven skills in leading/managing the execution of processes, projects and tactics
Knowledge in product regulations required including WEEE, REACH, RoHS, equipment safety directives and similar

RN Accreditation & Regulatory Manager Days Quality Resume Examples & Samples

Current CA RN license with a minimum of 8 years of experience in acute hospital setting
Bachelor’s degree required, preferably in a health-related field
Experience in facilitating regulatory surveys and surveyor visits for Joint Commission, California Department of Public Health, and Centers for Medicare and Medicaid
Experience in providing education, team facilitation and coaching
Excellent interpersonal, communication skills and presentation skills

Regulatory Manager for Corporate Office Resume Examples & Samples

A university degree in economics or law with a focus on banking
Experience within the financial industry in a central and governing function
Knowledge around EU/EBA regulations
Experience within a matrix function
A good understanding for the financial industry and its challenges
An analytical focus
A "can do" mentality
Stamina and robustness
A pro-active mindset and works self-guided through agreed priorities
Good communication skills and is able to orchestrate a variety of stakeholders
A strong team playing attitude
A diligent way of working and is reliable and can deal with confidential information in a compliant manner
Fluent English proficiency and is ideally able to speak either German/Italian or Spanish
Excellent MS-Office skills, especially in Excel and Powerpoint

Regulatory Manager Resume Examples & Samples

Implement R&D projects and achieve registration milestones
Support the preparation and submission of national registration dossiers
Serves as the interface between the Commercial, Marketing and the Research & Development Organizations
Provides regulatory and policy consultant of existing products sales and marketing teams as well as customers
A minimum of a Master Degree in Biotechnology, Life Sciences, Plant Protection or related areas (Ph.D. degree in the above areas is a plus)
Experience in pesticide and Biotech product registration
Excellent leadership
A great team player
Self-motivated, initiative and innovative, independent and hard working

Compliance Regulatory Manager Resume Examples & Samples

Act as Company coordinator for market conduct examinations of Cigna companies. Serve as liaison to insurance department examiners during the examination process
Assess market conduct issues and findings, communicate company position statements, develop appropriate responses and corrective actions, and negotiate outcomes to mitigate risk for the Cigna companies
Identify compliance gaps and work collaboratively with business partners regarding corrective actions
Communicate overall strategic direction to business partners relative to market conduct and practices
Complete all pre-examination surveys, data requirements and examination materials in an accurate and timely manner
Provide responses to examiner requests and criticisms within stated/negotiated timeframes
Utilize internal tracking tools, as appropriate, to document market conduct activities
Act as an advisor/consultant to business partners regarding regulatory examinations
Assist in the development of practices to address issues and to close compliance gaps and mitigate risk for the Cigna companies
Develop business partner relationships to assist in fostering a compliance environment throughout Cigna with mutual ownership
May represent Cigna on regulatory and industry committees and projects
Candidate must have previous experience working directly with Departments of Insurance, preferably with health care products. Minimum 5-8 years of compliance/regulatory experience is a must
Typically requires Bachelor’s or equivalent training and mastery; or any combination of education and experience
Master’s or JD degree preferred
Knowledge of Cigna products, systems and processes preferred
Strong knowledge of insurance, healthcare, legal, government/regulatory environment to understand and articulate compliance barriers and suggest compliant alternatives
Superior verbal/written communication and interpersonal skills required
Excellent time management skills with ability to multi-task in deadline driven environment with competing priorities
Ability to work and make decisions independently
Results oriented with ability and willingness to work in matrix environment

DRC Research Regulatory Manager Resume Examples & Samples

Experience in the administration of an Institutional Review Board
Outstanding written, verbal, interpersonal and organizational skills
Familiarity with PC applications, medical terminology, research design, statistics and academic and regulatory functions
Dedication to providing service
Ability to foster positive relations with multiple, diverse constituencies to influence and shape change
Strong customer focus (ability to listen attentively to residents/fellows and faculty and to understand and respond positively to their requests)
Ability to work under pressure, with the flexibility to respond to changing priorities and fluctuating workloads
Physical ability to move large bundles of paper and heavy boxes of paper
Certified IRB Professional designation preferred

Senior Regulatory Manager Resume Examples & Samples

As this role is strategically aligned with the operational and regulatory goals for SCE, Regulatory Affairs, and Customer Service, the Senior Regulatory Manager will frequently and proactively interact with senior and executive SCE and CS management as well as external regulatory representatives
Provide regulatory leadership, motivation, direction and management of a team of project managers and business analysts as well as cross-functional teams for the GRC and IQP and other CS-related major regulatory proceedings
Manage the development and processing of CS participation in major regulatory proceedings through frequent contact with key subject matter experts in CS and with other OUs
Manage cross-functional teams to develop supporting policy position for testimony, responding to discovery requests, and addressing ad hoc regulatory analytical projects based on executive CS management requests
Manage the development and implementation of regulatory policies and strategies to support participation in GRC and IQP regulatory proceedings
Manage the development of regulatory input and assessment for the corporate strategic planning process
Create and implement framework to identify strategies and tactics to accomplish goals and objectives of the GRC and IQP proceedings
Provide leadership, motivation and management direction to in regulatory proceedings
Timely and high quality execution while meeting executive leadership expectations on deliverables
Develop workforce capabilities by managing employee performance and development by conducting performance planning and reviews, coaching employees, and carrying out disciplinary action when necessary
Create a work environment which promotes working collaboratively by promoting effective teamwork between direct reports and across departments
Motivate best performance through continuous engagement and dialogue with a focus on problem-solving identified elements that distract achievement of the highest quality performance
Represent the company to various external organizations including electrical associates/affiliates, customer advocacy groups, manufacturers, other utilities, various governmental bodies, regulatory agencies and community/civic groups
Bachelor’s Degree in Business, Public Policy, Public Administration, Economics, Engineering, or related field
Must have four or more years’ experience in project management of cross functional teams or similar cross-functional coordination, and/or strategic planning, and/or energy markets, and/or regulatory policy development
Must have experience analyzing and interpreting energy related regulations, legislation or policies
Experience managing teams or cross functional teams developing regulatory documents such as Applications, Advice Letters, Direct and Rebuttal Testimony, and Comments
Typically possesses seven or more years of experience in regulatory affairs, operational programs, contact management, or function being managed plus seven or more years of supervisory or project management experience
Electric utility industry experience
Demonstrated knowledge of state and federal regulatory and/or legislative functions and processes
Customer focused to understand and respond appropriately to clients' business needs
Demonstrated ability to take initiative, be accountable for individual results, and motivate self and others to set and achieve high performance standards
Demonstrated strong organizational skills with high level of initiative and ability to effectively interface, collaborate, and partner with stakeholders, senior management, clients and team members to help drive solutions and ensure stakeholder buy-in
Proficient with Microsoft Word, Excel, PowerPoint, Project, and Visio
Ability to follow Edison safety protocols and safe work practices
Must demonstrate effective decision making, results delivery, team building, and the ability to stay current with relevant technology and innovation

Regulatory Manager Resume Examples & Samples

Understand and communicate relevant regulatory trends impacting Innovation and Renovation
Provide and manage regulatory and scientific input to confectionery product and process development
Provide regulatory advice to our Operating Companies and Nestlé HQ
Share regulatory knowledge through networks and provision of training
Support the development of advocacy plans to support business growth

China Trade Compliance Regulatory Manager Resume Examples & Samples

Strong knowledge of general China Customs and import/export laws and regulations, and China Customs policies and procedures
Familiar with China Customs organization, hierarchy, internal and external working mechanism
Diplomatic communication with government officers to address the case clearly with focus
Strong business sense with excellent trade-off in working
8+ years of experience in trade agencies or associations, or similar experience with strong expertise and background in trade compliance
A mix of compliance and program management experience
Excellent interpersonal skills enabling communication with professionals and people in various levels, and to operate effectively within a team environment
Experience in developing and implementing cross functional processes and procedures
Experience leveraging technology and data mining to drive process improvements
Working experience in trade agencies with senior or medium level rank
Ability to work on multiple concurrent tasks and projects

Quality Systems & Regulatory Manager Resume Examples & Samples

FDA/cGMP Compliance
Interpret Existing or New Regulatory Requirements as they Relate to Company Products/Operations and Procedures, Testing, Records, Etc. to Ensure Ongoing Compliance
Provide Regulatory Guidance and Support to the Organization Including Regulatory Filing Strategies, Policies, Procedures and Standards Requirements
Review, Provide Feedback and Approve Process and Manufacturing Changes, Non-Conforming Materials, Test Protocols and Reports Ensuring Regulatory Compliance with FDA/cGMP and Other Applicable Standards
Conduct Internal Audits of QC Lab, Operations, Manufacturing, Labeling, Etc., and External Suppliers
Represent the Company with External Regulatory Officials Including Onsite Visits and Written Communications
Initiate and Implement CA/PAs Identifying and Addressing Findings, Issues and Non-Compliances
Investigate Product-Related Customer Complaints as Pertains to cGMP Compliance and Manage the CA/PA Process
Assure Quality and Manufacturing Processes Comply With cGMP and Other Regulatory and Industry Standards
Author and Update SOPs
Lead and/or Support Investigations into Variances, Non-Conformances, Complaints and Quality Issues Assuring Proper and Enduring Changes are Made
Ensure All Manufacturing and Packaging are In-Compliance with Manufacturing Directions
Produce Weekly and Monthly Reporting Package with Relevant Metrics and Goals for Quality Processes
Create Documented Processes for Major Functions and Ensure Employees Are Following Processes
Support Company Initiatives, Especially the Company’s 123SQP Plan
Lead the Company’s Recall Program Including Lot Traceability and Mock Recalls

100

Product Regulatory Manager Resume Examples & Samples

Managing a global registration project including meeting milestones, identifying risk, and communication with regional regulatory authorities, and local and global sales and marketing teams on timelines
Maintaining most up-to-date information in regards to government legislation as it relates to regulatory or scientific affairs
Contributing to global product planning and launch teams to ensure timely product introduction by providing regulatory support and recommendations for new products
Bachelor's degree, preferably in a science major
5+ years of Regulatory Affairs experience
Prior experience with pharmaceuticals, natural medicines, or dietary supplements preferred
Strategic thinker, with forward planning and project management skills
Will consider candidates with a senior sales/business development background in the following arenas; pharma, nutraceuticals, ingredients, who would be open to taking on the Regulatory aspects of this position

101

Human Research Protection Regulatory Manager Resume Examples & Samples

Under government guidance, the contractor is responsible for the operation and management of the Regulatory Affairs and Research Compliance program
Ensures compliance of research programs with applicable sponsor, local, state and federal regulations for human subject research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA)
Assists in the development and updating of the DVBIC regulatory compliance policies, standard operating procedures, requirements and related matters
Establishes training programs in human subject protection and HIPAA compliance
Conducts research compliance monitoring
Obtains Scientific review of proposals and protocols
Facilitate information flow and acts as liaison between agencies such as USUHS, Federal and Contractor Principal Investigators and research staff, administrative staff, Institutional Review Boards (IRBs), Institutional Animal Care and Use Committees (IACUCs) Institutional Bio-safety Committees (IBCs), research administration offices, Food and Drug Administration (FDA), Office of Human ResearchProtections (OHRP)
May conduct site monitoring visits to ensure compliance with regulations and human subjects protection
May encounter patients who are confused, agitated, or abusive
Minimum 5 years related experience in clinical program management and 10 years’ experience in clinical research and/or regulatory affairs arena required
The contractor will normally work up to 40 hours a week, 0800 to 1630, Monday through Friday (hours may vary)
Must be available to travel locally, regionally and nationally

102

Regulatory Manager Resume Examples & Samples

Leading, and being a core contributing member of multi-disciplinary teams across Centrica developing and agreeing our strategic response to Ofgem investigations relating to energy regulation, combining commercial, Legal and Ethics & Compliance team resource and external advisers as appropriate
Leading on the preparation of submissions to Ofgem relating to energy investigations, and stakeholder meetings on related subjects
Management of key relationships within Ofgem relating to regulatory investigations

103

Quality / Regulatory Manager Resume Examples & Samples

Responsible to create and implement organizational standards and procedures to comply with applicable regulations
Responsible for developing and maintaining relationships, as necessary with regulatory agencies, customers or supplier quality representatives
Keep informed regarding pending regulatory changes, trends, and best practices and assess the potential impact of these changes on organizational processes
Manages non-conforming material’s review board (MRB) system including WIP rejects and incoming materials
Support operations management in assessing material and process defects in support of corrective action programs
In conjunction with the Materials function, actively and continuously pursue improvements in supplier quality, OTD, auditing, and supplier corrective actions
Interface with multiple departments, levels of management, customers and Suppliers
Complete and disseminate quality metric reports
Maintain ISO certification, perform audits and work with auditors to improve processes
Will travel up to 25% to customer and vendor sites
Lead special projects as assigned
Support the Management of Daily Improvement (MDI)
Responsible for the overall management of the Quality/Regulatory Department, including staff supervision
Bachelor’s degree in Engineering or other technical discipline preferred
10+ years of progressive experience in Quality Assurance/Regulatory Compliance and a minimum of five years management/supervisory experience in a Quality/Regulatory role
Comprehensive knowledge of quality assurance practices and processes
Excellent knowledge of ISO 9001 and 13485
Internal auditor and continuous improvement experience required
Excellent written/verbal/teaching skills with attention-to-detail
Demonstrated PC, Microsoft Word, Excel and Access database skills
Experience or trained in Six Sigma methodologies, TQM, Lean fundamentals preferred
Must have a working knowledge of quality programs, with experience in a variety of measuring/inspection instruments, auditing processes and closed loop corrective action programs
Formal experience and training in multi-disciplined project/program management required
Ability to work in both a team environment and autonomously
Excellent listening skills and attention to detail
Multi-task oriented with ability to manage multiple projects and ensure goals and timelines are met
Maintain composure and professional approach when dealing with public
Ability to make decisions logically
Capable of focusing on details with regard to procedures and workflow

104

Regulatory Manager for India Resume Examples & Samples

Member of the global MPP regulatory & standards core team
Responsible for the regulatory & standards strategy for MPP in India and supporting R&S activities in ASEAN countries
Responsible for effective relationship management with Targeted Regulators, Professional Influencers and Thought Leaders in the broader industry and its stakeholders
Participation & Leadership in targeted standard setting organizations, in particular with Bureau of Indian Standardization (BIS)
Participation & Leadership in targeted industry associations
Support the demand creation through influence and education with key government agencies and influential industry associations for medical device and pharma manufacturers as well as hospitals in India
Support and provide training to local DPS organizations in identified AP regional countries (ASEAN) on regulatory topics, strategy and key activities for local regulatory engagements
Develop a regulatory map & knowledge base to identify key regulatory issues, stakeholders, activities and events for India and AP regional countries
Establish key milestones and measurements of success for regulatory influence work streams and ensure the progress is on track
Support other functions (such as quality, technical) to provide regional regulatory guidance
Support the MPP SPM account management process
Support the MPP MDM outreach and key account management processes
Support the MPP Healthcare Outreach& Thought Leadership Initiatives
8 - 10 years of experience in dealing with medical and/or pharmaceutical regulatory issues. Experience in the development of standards is an asset. Knowledge of sterilization and packaging standards is an asset

105

Regulatory Manager Carbone Cancer Center Resume Examples & Samples

Minimum 4 years of clinical research and/or regulatory experience required, oncology experience preferred
Prior experience with Institutional Review Board (IRB) application process required, 3 or more years preferred
Respect: Demonstrate respect for self and others--behave professionally
Integrity: Act with integrity and honesty
Teamwork: Commit to and demonstrate teamwork
Excellence: Ensure excellence, quality, and high ethical standards in conduct and performance

106

Regulatory Manager, Flavors Group Resume Examples & Samples

Supports internal customers (including Customer Service, Sales, Research & Development, Quality Assurance) by serving as subject matter expert in assigned areas by interpreting regulations, providing information to address external customer needs, providing guidance in the development of products to internal customers, and by accurately maintaining product information databases
Supports external customer by providing routine or standard technical information in areas of subject matter expertise / core technology. Serves as the primary resource for non-routine or confidential information disclosure
Provides explanation of compliance strategies for Sensient Technologies products and discussion of product and compliance options. Provides information on and responds to requests regarding emerging issues, impact of proposed regulations and possible applications of Sensient Technologies products and labels
Propose new procedures or adjust existing ones when necessary. Adheres to regulatory procedures to assure compliance to Sensient Technologies. compliance policies
Utilizes authorized Sensient Technologies systems for maximum efficiency and consistency. Places responsibility for compliance with function closest to customer or agency for maximum efficiency and accountability
Audits adherence to policies and procedures as directed; recommends corrective actions(s); follows up to ensure that appropriate actions have been taken to achieve compliance
Establishes and maintains expertise in of the principles set forth in the food regulations for assigned core technologies, ingredient categories and associated regulatory agencies
Tracks, monitors and understand regulations for assigned core technologies and regulatory agencies, and assesses impact on Sensient Technologies business. This can include participation in professional societies and trade associations and contacts with industry colleagues
Actively cross-trains with others to relieve high volume issues and maintain a balance of workload within the department
Trains and communicates information to appropriate personnel. Actively listens and shares information and knowledge with others in an effective and a timely manner. Ensures that appropriate information is communicated, received and understood
Demonstrates the technical/functional skills to fulfill the needs of the role and continually develops expertise. Actively pursues personal development to improve and add skills in order to effectively apply expertise internally and externally
Demonstrates the flexibility and ability to adapt to a changing environment
Provide external representation of Sensient Technologies. interests with regulators and regulatory agencies and with other authorities and institutions
Develops relationships inside and outside the organization to enhance personal and company effectiveness
Specific assigned responsibilities with regulators and agencies can include
Application for, amending and renewal of permits, registrations and licenses
Managing or contributing to audits or inspections
Seeking clarification on existing, or commenting on proposed regulations, guidelines or standards
Preparing and submitting information for required filings and reports
Represents Sensient Technologies. interest in external organizations, including presentation of Sensient Technologies. position on specific issues and topics; or provide knowledge and expertise for representation by others, as requested. Update concerned groups as necessary
Drives technical initiatives, with the ability to work across functions
Systemic problem solver, implementing solutions to solve root cause problems. Strong analytically
Works well within a team structure, has the ability to influence without direct control, can sell ideas and articulate business benefit of functional initiatives
Ability to take a stand while working in a team environment
A minimum of a Bachelor of Science degree in food science, chemistry or related field
10 years of industry experience in regulatory and/or quality, or similar function required to address compliance with food and beverage regulations
Knowledge and understanding of food composition and chemistry is required
Ability to judge the applicability of technical information from unrelated sources to issues specific to Sensient Technologies products and raw materials
Strong knowledge of local, region, and global federal regulations and government agencies. Extensive knowledge of regional and international food and beverage regulations and their application
Industry-specific knowledge of ingredients, food allergens, ingredient functionality and product formulas
Computer skills – Word, Excel, PowerPoint, etc. Comfortable managing with facts and data vs. subjectivity
Keen attention to detail and precise execution of policy
Ability to develop vendor relationships
Demonstrated ability to effectively organize and manage numerous work tasks of a diverse nature
Demonstrated ability to review, interpret and apply sometimes vague regulations to complex formulas. Demonstrated ability to review, interpret and summarize technical information(e/g/ laboratory analyses, processing technologies)
Strong written, oral and facilitation skills. Ability to maintain communication composure with outside agencies
Excellent listener. Empathetic to individuals concerns and directs necessary follow-up actions
Conveys information in understandable terms at all levels of the organization
Ability to evaluate and communicate risk; communicate details for fact based decision making
Personal and social competence
High integrity and honesty, promoting trust in all actions
A lifelong learner who continues to develop expertise of in the area of regulatory compliance
Enjoys working in a results-oriented, customer focused, team environment
Works well under pressure situations and tight timelines
Primary language English, Secondary language of French, German, Italian or Spanish preferred
High energy. Assertive, energetic, and a self-starter

107

Regulatory Manager Resume Examples & Samples

Ability to rapidly adapt to different issues and projects at one time
Ability to work with multiple priorities
Ability to adapt to new priorities
Ability to manage several parallel, ongoing activities
Cope with strict timelines, urgencies
Demonstrates high level of self motivation and professional commitment
Solid scientific background (university degree of chemistry, life sciences, pharmacy, medicines, PhD level desired)
Good understanding of the pharmaceutical industry and have an understanding of European Centralised Regulatory Procedures
2-3 years of direct (or relevant) hands-on experience in regulatory procedures (preferably)at the European level
Industry experience in related function is desired
Great communication, organization and attention-to-detail skills
Strong team spirit and supporting attitude

108

Benelux Regulatory Manager Resume Examples & Samples

Manage legal / RA questions concerning products of ADC
Manage questions from local health authorities
Manage product documentation
Interact with national governmental bodies
Interact with European governmental bodies
Lead public procurement processes
Advising role concerning strategies and regulatory requirement
Advising in the interpretation and application of IVD regulations as well as the planning and implementation of new and updated regulations
Review advertising and promotional materials for regulatory compliance
Strengthen Regulatory Affairs in the DNA of the organization
Reporting to the country manager BENELUX

109

Global Regulatory Manager Resume Examples & Samples

Work with Global Regulatory, other Deloitte Global groups (i.e. Global Audit, OGC, Risk, Public Policy, the Global CEO’s office, etc.) and member firm leadership to support regulatory programs and initiatives
Prepare briefings and support planning activities in conjunction with Global leadership regulatory internal and external interactions
Attend meetings with Regulatory leadership, take notes, and provide briefings and other support to execute agreed-upon action items as needed; monitor execution of action items
Develop tools, templates, and guidance necessary to support execution of regulatory initiatives
Conduct research and summarize the results on key strategic issues in the global regulatory environment
Draft communications and resources to educate Deloitte member firms on relevant regulatory matters, as well as to educate specific audiences such as clients, where relevant
Provide support on other strategic and/or ad hoc projects
Some international travel is expected
3 - 5+ years of working experience in audit or legal; risk management or project management experience is a plus
Experience working in a professional services environment strongly preferred
Deloitte network experience preferred, but not required
Excellent communication and presentation skills, with the ability to translate quantitative and qualitative analyses into clear messages for the audience
Strong Microsoft Office suite skills and strong quantitative background are required (strong focus on PowerPoint skills)
Comfortable working in a global, matrixed environment
Ability to deliver under pressure and provide informed responses to leadership in short timeframes
Ability to handle sensitive leadership information with utmost confidentiality
Ability to be self-directed and responsive
Project management skills and demonstrated experience successfully working within a cross functional and cross-border team
Flexibility for limited international travel

110

Regulatory Manager Resume Examples & Samples

Establishes the H-E-B Own Brands labeling regulatory guidelines with the Own Brand leadership team
Ensures that regulatory strategy for every Own Brand product meets the corporate Own Brand strategy
Bachelor's Degree in Language Arts or Communication or related field or comparable experience
10+ years experience in labeling and / or regulatory
In-depth knowledge of product and food labeling (USDA, FDA, FTC and NAFTA)
In-depth knowledge of Standard Operating Procedures of federal regulatory entities (USDA, FDA)
Minimum of three years of prior management experience
Proficient in Microsoft Office Suite-- Word, Excel and PowerPoint
Knowledge of Mexican packaging/labeling laws (NAFTA)

111

Product Stewardship & Regulatory Manager Resume Examples & Samples

Provide global strategic feed innovation & approvals coordination and advocacy support across industries and regions
Collaborate with individuals at varying company levels with global coordination focus
Coordination of global regulatory compliance for marketed IB products touching the feed industry, in conjunction with regional regulatory staff and product management supporting food industries
Global focus on key trade associations across all regions; work with regional team leads on key DuPont IB animal feed & health issues to ensure globally aligned positions
Identify and communicate changes in policy; coordinate global efforts across regions to influence national regulations in areas related to the Bioactives feed business through strong advocacy and leadership
In depth knowledge and recognized for leadership & innovation in managing animal feed and/or animal health regulatory or similar program

112

Internal Audit Senior Regulatory Manager Resume Examples & Samples

Serves as an internal consultant to the business and technology auditors across the audit group regarding business risks. Applies a significant depth of expertise in business and/or technology risk and control related matters to enable audit teams and ensure risk is properly evaluated in audit work. Leverages technical business expertise to influence appropriate audit coverage and assurance, such as investment instruments and product intricacies, regulatory considerations on a global scale (including the broker-dealer landscape) and/or Sarbanes-Oxley depth
Owns a portion of the audit plan and the associated senior business leader relationships. Manages, plans and executes the audit activities for the business areas assigned. Develops the audit strategy for specific audits that includes clearly defined identification of risks, control objectives, and audit approach. Directs the preparation of or prepares detailed audit activities to be performed to accomplish the audit strategy
Leads and manages complex audit projects for the organization assessing business and technology risks. Serves in an advisory capacity in support of enterprise-wide initiatives related to new business ventures and technologies (Vanguard programmatic strategic initiatives) being implemented locally and or globally
Leads discussions and consults with audit, business and technology leaders to assist in the development of an annual plan. Works closely with all levels of management in the planning, development and execution of short and long term goals. Demonstrates initiative and creativity in independently recommending and implementing solutions
Evaluates audit results ensuring the quality of the audit activities and the audit requirements are met in adherence to the professional standards of internal auditors and in keeping with our position as the independent third line of defense for the organization. Ensures audit deliverable is accurate, complete, and addresses key risks
Performs research to understand new business activities, technologies, data, associated risks, and the application to Vanguard’s business and technology environment to support specialized topics across multiple domains
Undergraduate degree or equivalent combination of training and experience. CPA, CIA, CFA or MBA also preferred as related to one’s area of expertise
Eight to ten years of experience in the audit profession required; five years of project management experience with experience in shaping / implementing future strategies preferred
Excellent leadership, interpersonal, verbal and written communication, presentation, and problem solving skills
Ability to lead and motivate others
Experience in situations requiring diplomacy and negotiation
Strong client focus and relationship skills
Advance organization integration

113

Lawn & Garden Regulatory Manager Resume Examples & Samples

Develop and implement robust regulatory strategies to support L&G-related portfolio of assigned active substances and products in China through
Planning, project management and issue management skills
Negotiation and advocacy skills
Good understanding of the L&G Business
Regulatory experience in China
5-10 years in Reg. Sciences

114

Logistics Regulatory Manager, China Resume Examples & Samples

Contributes to the development and execution of the Global Logistics Operating Plan in terms of regulatory requirements
Research and determine import and export requirements of international and country-specific regulatory bodies (MOH, CIQ, DOH, SFDA etc.) in China and current countries serviced
Develop and implement appropriate communication channels to support all functions in China across R&D Labs for their specific regulatory requirements
Develops systems that assure compliance with regulatory requirements across the R&D Labs and monitors compliance with procedures and practices
Work in cooperation with the internal departments and external regulatory bodies to ensure a seamless flow of supplies movement to meet needs
Establish emergency contingency and shipment recovery plans and procedures to compensate for regulatory changes that may disrupt operations, such as customs closings, etc
Understand documentation requirements for international shipping and country-specific regulatory compliance, including dangerous goods regulations and restrictions, what level of detail is necessary, and what forms are needed and strictly comply with these requirements
Effective and timely adherence to management communications, meetings and procedures
Strict adherence to company corporate policies
Perform other duties as assigned by the Global Logistics management
Minimum of 5 years of proven experience in Logistics and/or Transportation within the CRO industry, or a reputable international transportation company or an international industrial company with track records of managing Logistics team
Minimun of 5 years of proven experience managing regulatory for an international company managing import/export of regulated materials and requiring regular contacts with government officials

115

Safety Compliance & Regulatory Manager Resume Examples & Samples

Ensure DOT, FRA, OSHA, EPA, DEQ, DNR, SITLA, DHS and all other applicable federal, state and local regulatory permits and compliance practices are implemented
Develop and maintain a list of external regulatory reporting requirements as well as the comprehensive calendar for reporting
Establish and maintain productive relationships with state, local, and other regulators
Maintain compliance with required filings and reporting, ensuring all agency filings are accurately completed and timely submitted
Implement onsite Process Safety Management program and procedures
Coordinate reporting and permitting issues with marketing, operations, and construction activities
Standardize, update, and produce written operating procedures and plans
Conduct regular compliance audits and trainings
Coordinate with Terminal Manager in the collection of relevant data to ensure up-to-date and accurate reporting
Develop and manage a system which provides for site document control
Coordinate provision of appropriate training resources to ensure all statutory and regulatory training requirements/needs are met
Conduct periodic safety inspections and initiate action to eliminate workplace hazards
Recommend installation of safety guards, safe working practices, and use of personal safety equipment
Support and/or lead (as requested) all accidents/incidents, maintaining complete accident statistics and records, ensuring subsequent action items resulting from investigation are resolved in a timely and satisfactory manner
Ability to understand and monitor Federal and State regulations, laws, and requirements
Ability to make appropriate, evidence-based, professional judgement when faced with complex issues and requirements
Understanding of regulatory language and ability to translate regulatory language into operational plans, processes, procedures, and reporting
Knowledge of regulatory divisions, structures, and processes including OSHA, FRA, FERC, EPA, DEQ, DNR, DOT, etc
Excellent interpersonal skills, including the ability to work with different departments and with various levels of company employees, customers, contractors, and government personnel
Demonstrate personal initiative and self-motivation
Strong organizational, planning, and analytical skills, ethical orientation, attention to detail, and ability to multi-task
Strong critical thinking, influence, negotiation skills, judgement, and ability to conduct professional meetings
Conversant with environmental reports and government approvals; experience with leases, contracts, bonding, insurance, mining/construction permits, conditional use permits, surveys, easements, construction documents, entitlements, site compliance, and cultural resource and environmental mitigation
Excellent communication skills, both written and verbal; strong business writing ability
Proficient in MS Office (Outlook, Word, PowerPoint, Project, Access, and Excel), AutoCAD, Adobe Suite
Must be committed to working safely at all times
Maintain a valid driver’s license
Bachelors degree is preferred
Education or working knowledge in land use development, public administration, regulatory affairs, law or a related field is preferred
Experience and understanding of PSM principles is highly desired
A recognized certification or experience in project management is desirable
The employee must occasionally position, transport and/or move up to 25 pounds
While performing the duties of this Job, the employee is regularly required to

116

Regulatory Manager Resume Examples & Samples

Responsible for filing of clinical trial applications to the Health Authorities in the Nordic countries, and all following interactions, in line with BMS company policies and practices, the EU clinical trial directive and the local legislation
Streamlining and simplifying of local work processes for clinical trial applications, and to ensure alignment of these with the new EU clinical trial regulation
Monitoring local health authority requirements related to the implementation of the new EU clinical trial regulation and to ensure integration of these in the local working processes
Foster a close collaboration with the local Clinical Operations department
University degree or other relevant higher education within health care
Preferably at least 2 years experience in pharma industry, either in clinical trial or regulatory departments
Excellent knowledge of MS Office (Word, Excel and Power Point)
Knowledge of the Finnish language is a big advantage
Good communication and interpersonal skills - ability to work in a team, support and foster team spirit and facilitate best practice sharing
Good project management and organization skills
Drive and can do attitude. Proactive mindset with commitment to meet and exceed external and internal stakeholder’s expectations
Service minded, independent and able to organise the daily work in a structured way

117

Regulatory Manager Resume Examples & Samples

Manage submission activities in the L&G area by partnering with key stakeholders (i.e. commercial, biology and project managers, Global/Regional/Country regulatory
Manage all activities of assigned products that are specific to L&G and assure that agreed, existing L&G uses and L&G products are registered on the AME market
Agree with key stakeholders on the projects to go forward and on the relevant gaps to be defended and registered
Make sure that all involved functions such as Product Safety and L&G Biology, deliver their tasks in a timely manner and on purpose
Develop knowledge in EU and AME registration processes and requirements for biocides and provide guidance to stakeholders accordingly
The person will report to the Lawn & Garden Team Lead within the EAME Regulatory Portfolio
Collaborate with key stakeholders to develop the AME L&G portfolio and deliver the required registrations
Carefully identify L&G products that need AME registration activities. Drive the preparation of L&G registration dossiers and deliver them according to plans, to AME countries
Identify and properly plan resources/time/budget for delivery of registration dossiers
Identify, drive and coordinate activities, engage resources, that are needed to deliver assistance to AME countries for answering questions from authorities on L&G products and to get registration dossiers complete and ready on time. Deliver registration dossiers to countries
Recognize issues or opportunities that can affect or influence projects, inform customers and respond quickly to resolve problems, e.g. with authorities, or to propose options to achieve desired outcomes
Alert L&G Global regulatory team on all internal and external issues and opportunities that can impact global L&G projects and propose strategies that overcome issues and/or accelerate "go to market"
In depth knowledge of licence to sell principles and requirements
Technical background with some knowledge and experience of AME regulatory requirements
Solid knowledge of internal processes or ability to quickly acquire knowledge of internal processes
Technical background, Degree in science
Minimum 2 years of working experience in registration or relevant development business area
Good networking and communication skills across international dimensions. Team player
Capability to lead team geographically dispersed and cross functional
High organisational skills, attention to detail and ability to complete and deliver projects on time
Proactive behaviour
Excellent analytical thinking ability
Open to novelty, "unusual" solution, pragmatism
Ability to recognize issues or opportunities and to create relevant alerts or options
Potential and ambition to develop into broader Regulatory Manager role as experience develops
Collaborate across boundaries
Focusing on delivery the dossiers according to plans

118

Air Permit / Regulatory Manager Resume Examples & Samples

Partner with businesses to review proposed project changes to evaluate permitting needs and provide optimal solutions to ensure project timelines are met and emission increases are minimized
Lead air approval projects through the preparation of permit (NSR, NNSR, PSD, PBR, Standard, Title V off-permit notifications and minor and significant revisions) applications and agency negotiations to ensure optimal permit conditions that provide competitive advantage, frequently working with consultants
Partner with plant personnel in the implementation of air approvals into plant operating discipline by providing interpretation guidance and inspiring open communication and leveraging between plants
Coordinate agency information requests to ensure accurate, timely responses
Lead Dow personnel in inspections/investigations (both on-site and “records review”) by local, state, or federal agencies in a mutually respective environment
Provide technical input and/or lead efforts to evaluate Industrial Park impact to permits on integrated sites
Function as site focal point to support and lead preparation and submittal of routine compliance reports to agencies
Assist plants in preparation of Title V Deviation reports and other regulatory reports, driving a standard of excellence is site consistency in reasonable inquiry and deviation reporting
Review proposed project changes to innovatively evaluate permitting needs
Facilitate optimal compliance issue resolution by valuing diversity of team members
Evaluate impact of proposed regulations on site plants and facilities; provide constructive comments to agencies for flexibility that is protective of the environment
Facilitate sustainable implementation of new regulations in site facilities
Calculate netting of key emissions (NOx, CO, PM, VOC, GHG)
Pursue an excellence in operating discipline to ensure consistency among site and state air permit writers
Partner with consultants to perform impacts and other modeling
Coordinate Texas EH&S Audit Privilege correspondence as service to clients
Work schedule is optional 9/80 or conventional 5 - 8's
Work is primarily in the office, with minimal travel to Austin and occasional visits to plants
Experience in Texas air permitting (application development and negotiating conditions/limits) for chemical/petrochemical production facilities is preferred
Manufacturing experience in chemical/petrochemical plant operations is preferred
Experience with agency investigations is preferred
Ability to handle a variety of tasks simultaneously and prioritize effectively to meet internal and external deadlines is preferred
Demonstrate strong written and oral communications skills, as this position requires interaction with various levels of Dow management, as well as interaction with government agencies is preferred
Demonstrate strong logical thinking and computational skills in order to ensure compliance with permit limits is preferred
Enthusiastically pursue a standard of excellence by developing innovative solutions to provide maximum operational flexibility and competitive advantage is preferred
Must have a strong sense of integrity is preferred
Value working constructively in teams, as well as independently is preferred
Ability to lead project meetings and giving presentations to small and medium sized groups of people is preferred
Proficient in standard MS Office applications (Word, Excel, PowerPoint) is preferred

119

Regulatory Manager Resume Examples & Samples

At least 7 years of bio-pharmaceutical industry experience with a doctorate degree or 10 years of experience with a Bachelor's degree of which at least three should include relevant regulatory affairs experience (eg antibodies)
Understanding of biologics work processes
Expertise in the interpretation and communication of CMC regulatory requirements for site product and process issues
Working knowledge of US and EU regulatory requirements for biologicals
Ability to interpret compliance requirements for the creation or review of protocols and site documentation
Agencies and Industry trends across all areas of GXP to anticipate the needs of both the company and the customers and communication of these trends
Demonstrated skills managing project timelines
Proven experience of preparing and authoring IND, NDA/BLA, and CTD submissions for biological products
Proficient with Microsoft Office products
Superb organizational skills and attention to detail
Demonstrated ability to manage priorities and work under tight timelines
Able to work in a diverse environment to obtain solutions based on a solid background and understanding of the company procedures, regulatory guidance, current legislation and company objectives
Able to communicate a site regulatory compliance philosophy internally and to clients
Demonstrated ability to work well with cross functional teams
Ability to review and critique complex technical documents
Strategic approach and system oriented toward goals and objectives
Ability to represent the company on regulatory issues both internally and externally
Strong interpersonal skills and ability to interact positively with all functions
Excellent team leader as well as committed team member
Strong written and verbal communication; ability to present to various audiences’ levels

120

CMC Regulatory Manager Resume Examples & Samples

Bachelor degree in pharmacy, chemistry or related scientific discipline or equivalent qualification
Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early life cycle submissions
Detailed knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development
Proven ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy
Successfully influenced and negotiated issues at a senior level within your organisation and with regulatory agencies in a variety of settings
Proven ability to manage and direct multiple projects/teams simultaneously with excellent team working abilities and adjust to changing priorities
Experience in corporate evaluation and provision of CMC regulatory advice to in-licensing and divestment projects
Experience of being involved in/leading business critical activities within and external to the organisation
Manage, or be responsible for, the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities
Strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and early lifecycle activities
Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications
Work in cross-functional matrix project teams, which include colleagues from regulatory, chemical and pharmaceutical development and manufacturing
Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment

121

Senior Global Program Regulatory Manager Resume Examples & Samples

Strong knowledge of regulatory submission and approval processes in 1 or more major regions
Experience leading regulatory submissions and approvals in at least 1 major region
Experience in a global/matrix environment or crossfunctional teams in the pharmaceutical industry
4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas
Prior history with post-marketing/brand optimization strategies and commercial awareness preferred
Involvement in dossier submissions and approvals
Drug regulatory submissions and commercialization in major regions
Organizational awareness (e.g., interrelationship of departments)

122

Senior Regulatory Manager Resume Examples & Samples

Review TCCC flavors for compliance with government and Company requirements and develop regulatory documentation to support product development initiatives
Track, monitor and understand current, proposed and new flavor regulations to assess impact on the business as well as promote and participate in advocacy efforts
Formulate and propose positions on key flavor issues and develop proposed language for FAQs, advocacy discussions, and other settings
Establish, communicate, and enforce Company requirements regarding flavor regulatory issues
Collaborate with flavor suppliers’ regulatory departments regarding compliance activities
Actively work with trade organizations including Flavor Extract Manufacturer’s Association (FEMA) on flavor issues of importance to the Company and the industry and represent the Company on relevant committees
Create flavor regulatory training modules and train internal and external stakeholders
Work with Company regulatory managers worldwide to obtain and maintain key flavor and labeling regulations and to consult on their meaning and application
Flavor Regulatory Knowledge: General knowledge of the flavor regulatory landscape that affects the food and beverage industry. Understands the flavor regulatory frameworks of different countries. Ability to interpret global flavor regulations. Is aware of the major flavor regulatory issues facing the food and beverage industry
Flavor Regulatory Documentation: Ability to review, interpret and summarize complex regulatory and technical information and develop regulatory documentation such as legality certificates, natural status certificates and allergen statements for use in compliance reviews
Flavor Industry Knowledge: Knowledge of flavoring materials, the flavor industry and the trade organizations that represent them
Proprietary Composition Information: Ability to recognize and protect proprietary information as it relates to formulas and ingredients
Flavor Chemistry: General knowledge of the chemistry of essential oils and other flavor compounds relevant to Company products

123

Senior Regulatory Manager Resume Examples & Samples

Provide expertise to guide the business in finding solutions to hazard communication and chemical regulation compliance issues that affect our products, ingredients, and labels
Ensure information in Master Database related to hazard communication is accurate and current based on available information
Establish, communicate and enforce Company requirements regarding hazard communications
Provide support and guidance on Safety Data Sheet (SDS) requirements
Maintain a strong network of experts, government agencies, industry peers and other stakeholders needed to maintain a favorable regulatory environment for the company. Represent the company externally on relevant trade and scientific organizations
Influence, review and monitor new/changing global regulations so that leadership can be proactively informed of emerging hazard communication and chemical regulatory issues that are an impact to the business and identify strategies to address them. Interpret, assess business impact and implement new regulations as required
Partner with the business and internal manufacturing to identify needs to meet current and future requirement for hazard communication
7+ years relevant work experience. Experience in the fields of hazard communication, Safety Data Sheets, and transportation classifications, preferably with a flavor/fragrance, consumer product or chemical company
Hazard Communication and Chemical Regulations Knowledge: General knowledge of hazard communication and chemical regulations as it applies to ingredients, flavors and beverage bases. Ability to interpret global hazard communication and chemical regulations
Hazard Communication and Chemical Regulatory Landscape: General knowledge of the hazard communication and chemical regulatory landscape that affects the food and beverage industry. Understands the regulatory frameworks of different countries. Is aware of the major regulatory issues facing the food and beverage industry
Build Technical Relationships: Ability to apply technical knowledge and establish credibility with highly technical audiences in order to build relationships. Advocates a position in a non-adversarial manner
Technical Requirements: Ability to develop and implement company requirements and guidelines on hazard communications

124

Senior Regulatory Manager Trade & Industry Resume Examples & Samples

Responsible for leading the Regulatory Analysis function within Oriflame ensuring the business impact on Oriflame portfolio of new legislation in cosmetic and food and food supplement areas is minimised
Support Senior Director Global Regulatory Affairs in the on-going development and implementation of the global regulatory strategy aligned with R&D and overall company strategy
Management of the Global Regulatory Analysis team in R&D in line with Oriflame requirements and career development aspirations
’Dotted line’ management of Oriflame Regional Regulatory team ensuring focus areas and targets are aligned with Global Regulatory strategy
Work with Senior Director Global Regulatory Affairs in developing the future strategy for Oriflame’s advocacy/lobbying efforts at Trade Association level
Represent Oriflame on relevant National & European Trade Association Committees/Working Groups
Responsible for building effective network of external regulatory contacts across industry thereby enabling stronger lobbying positions on regulatory matters important to Oriflame
Build and maintain a high level of expertise and knowledge in the regulations affecting compliance of cosmetics and food/food supplements in all Oriflame markets
Effective and proactive communication of regulatory challenges and risk areas to senior management within the organization
Post Graduate qualification in a scientific discipline is required
At least 5 years experience in a senior regulatory role preferably within the cosmetic or food/food supplement sector
Broad experience in representing a company at trade association level is required
Broad knowledge of regulations relevant to cosmetic or food/food supplements in global markets is mandatory
Proven track record of successful communication of regulatory matters to various non-technical audiences is required

125

Regulatory Manager Resume Examples & Samples

Obtain approval for specific Syngenta products in the Nordic countries (Norway, Sweden, Finland & Denmark) to timescales agreed with Regulatory Lead and Commercial Unit
Actively contribute to securing Syngenta’s competitive edge through top quality submissions and handling registration issues in an ethical, trustworthy way with Nordic authorities
Knowledge on the Nordic/EU PPP (Plant Protection Products) matters
Knowledge on PPP legislation and legislation connected to PPP authorisation in Nordic countries and at EU level
Knowledge of the technical disciplines related to PPP registration; toxicology, product residues, environment fate and ecotoxicology at a general level
Deliver value adding solutions to the Nordic CU business
Effective collaboration within the regulatory team
Internal & external networking
High attention to detail whilst keeping the overview
General understanding of agriculture and horticultur business
Practical registration experience
A degree in Science
Experience in building and maintaining relationships
Proven cross functional working capabilities
Proven experience in providing solutions to complex issues
Proven communication, negotiation, influencing and analyttical capabilities
Fluent in Danish/Swedish and English
Capability to work in highly structured and independent manner
Excellent administrative skills (attention to detail whilst maintaining the overview)
Excellent project management capabilities
Ability to act in a trustworthy and responsible manner
Ability to multi task on different levels
Networking capabilities to effectively build and maintain a solid internal and external network
Ability to act as a decisive team player
Ability to prioritise and deliver goals on time
Sets ambitious strategic goals
Manages for performance
Collaborates across boundaries

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