Regulatory Director Resume Samples

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A Gorczany

Addison

Gorczany

2215 Gaetano Key

Phoenix

+1 (555) 765 2489

2215 Gaetano Key

Phoenix

Phone

p +1 (555) 765 2489

Experience Experience

Detroit, MI

Director of Quality & Safety Regulatory

Detroit, MI

Bartell-Bailey

Detroit, MI

Director of Quality & Safety Regulatory

Performs other duties as assigned
Coordinates the regulatory compliance program to meet the standards identified by the JCAHO, DPH and CMS, including the National Patient Safety Goals. Support project structure to insure all staff is involved in regulatory readiness on a daily basis, including tracer rounds with defined tools and processes that include feedback from the patient and/or family, rounds with
Works with administrative and clinical leadership to insure they recognize their role in preparation for regulatory readiness. Is supported by the hospital leadership in assuring this process is hospital wide
Prepares reports, tracks responses, and coordinates communication regarding quality and safety issues to external regulatory agencies
Serves as liaison between Hospital Leadership and the system level regulatory groups to aggregate data and make recommendations on matters that affect compliance with quality and patient safety standards
In coordination with the Sr. Director of Quality and Safety (Corporate level) and the Risk Manager manages all survey activities from arrival, coordination of survey activities to exit exercises inclusive of successful completion of any action plan associated with the survey process to ensure ongoing accreditation
In coordination with Risk Management personnel, investigates patient safety failures and issues within the system, participates in Root Cause Analysis of internal error reports and critical event reviews

Detroit, MI

Managing Director Head of Regulatory Consulting

Detroit, MI

Nitzsche, Kub and Wiza

Detroit, MI

Managing Director Head of Regulatory Consulting

Lead and manage presentations for senior executive management
Solves client conflicts at senior executive management level
Serve as head of the newly created Consulting Americas Regulatory practice
Provides honest and independent advice
Stay abreast of relevant regulatory developments
Writes sharp and straight-to-the-point management summaries
Manage and motivate resources at all levels

present

New York, NY

Finance & Risk-regulatory & Compliance Principal Director

New York, NY

Dooley, Kirlin and Bogan

present

New York, NY

Finance & Risk-regulatory & Compliance Principal Director

present

Interaction is with senior management levels at a client and/or within Accenture, involving negotiation or influencing on critical matters
Wide latitude in decision-making and determination of objectives and approaches to critical assignments
Decisions have a major and lasting impact on areas outside of own responsibility
Manages large complex teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
Architect and deliver consulting solutions and services and provide sales support within a clearly defined area of industry expertise that is supported by the business
Add credibility to Accenture's reputation during the sales process and deep expertise through delivery phase
Contribute to and lead asset/offering development and thought leadership activities through points of view, Knowledge Exchange, discussion boards, etc

Education Education

Bachelor’s Degree in Public Health

Howard University

Bachelor’s Degree in Public Health

Skills Skills

Experienced regulatory compliance officer at a director or similar senior level with multiple year experience in a sophisticated, multi-service line business environment
Strong personal communication skills, capable of dealing with a wide range of staff
Ability to take difficult decisions and provide substantiated arguments
Proven ability to devise and implement appropriate system and process improvements
Ability to lead, take responsibility and act autonomously
Ability to build relationships across the firm (jurisdictions and service lines), in particular with senior personnel
Current FCA approval as a Money Laundering Reporting Officer. The firm will apply for the necessary approval for the role with EY
Track record of dealing successfully with regulators
Effective planning and organising skills to prioritise key areas of responsibility, tasks and projects
Experience of team management and team leadership

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Global Cyber Regulatory & Audit Director Resume Examples & Samples

10+ years of business experience, ideally including 5+ years in Financial Services and 5+ years in Technology Risk or related fields
Strong organizational and time management skills; ability to manage multiple and conflicting priorities in a global organization, and to adapt in a fast-paced environment
Ability to both learn from colleagues and think outside the box

CCB Regulatory Program Control Director Resume Examples & Samples

10+ years experience in/knowledge of more than one of the following areas: banking or credit card operations, audit, compliance, operations control; Regulatory Compliance experience a plus
Excellent written and oral communication skills with the ability to present information in differing degrees of detail and forms depending on the audience
Ability to multi task and deliver to a tight deadline
Enjoy working in a fast-paced and demanding environment
Experienced and proven ability to gather/analyze complex data, develop accurate conclusions and provide recommendations with sufficient comprehension of the business to understand risk implications
Proven ability to build strong partnerships with colleagues, desire to learn quickly, be flexible and think strategically
Ability to work with internal groups including legal, audit, risk to ensure consistent understanding of requirements
Experience in business process analysis, documenting gaps and process standardization

Audit Director, ICG Regulatory Reform Resume Examples & Samples

Develop and execute the strategic direction of Citi’s Internal Audit (IA) function in the establishment of Markets Regulatory Reform related risk based auditing within ICG which includes reporting methodologies, organizational design and effective positioning of the function to ensure provision of independent assurance. This is to be consistent and aligned with Citigroup and Citibank business objectives
Use excellent communication, leadership and strong management skills to influence a wide range of internal audiences including respective product, function, or regional executive management partners and external audiences including regulators and external auditors. Frequently engages in both internal and external negotiations which will have a major impact on the function, and possibly on the organization as a whole
Directs audit activities related to global regulatory reform, in accordance with IA standards, Citi policies, and local regulations. Responsible for providing valued and timely independent assurance on the design and operating effectiveness of a sub set of a product, function, or legal entity at a global or regional level
Senior level experience in an audit related role with experience in business, functional and people management, with proven abilities in taking responsibility for executing concurrently on a portfolio of high quality deliverables to stakeholders according to strict timetables

Regulatory Director Resume Examples & Samples

Experienced regulatory compliance officer at a director or similar senior level with multiple year experience in a sophisticated, multi-service line business environment
Previous experience as an AML Officer / MLRO is essential
Track record of dealing successfully with regulators
Proven ability to devise and implement appropriate system and process improvements
Current FCA approval as a Money Laundering Reporting Officer. The firm will apply for the necessary approval for the role with EY
Proven ability to establish a high degree of credibility, respect and trust at all levels, but particularly with external stakeholders and regulators
Ability to lead, take responsibility and act autonomously
Ability to build relationships across the firm (jurisdictions and service lines), in particular with senior personnel
Strong personal communication skills, capable of dealing with a wide range of staff
Effective planning and organising skills to prioritise key areas of responsibility, tasks and projects
Experience of team management and team leadership
Advanced analytical and problem solving
Ability to take difficult decisions and provide substantiated arguments
Negotiation and influencing skills
Degree-level education and subsequent professional qualification, such as a qualified accountant, lawyer, or other regulatory compliance qualification would be an asset

Regulatory Relations Group Director Resume Examples & Samples

Managing and overseeing the Firm’s interactions with its Regulators in EMEA
Reporting to Firm Management and other governance and management bodies on Regulatory relationships and supervisory processes, including areas of significant regulatory focus or concern
Assist senior team members in management of regulatory information requests and regulatory remediation responses by coordination of responses from all contributors; setting up and maintaining SharePoint sites, consolidation and checking of responses / submissions; formatting and preparing documents for final submission
Manage the development and delivery of EMEA RRG management information including regulatory relations and regulatory response oversight information. Responsibility for creating timely, accurate and strategic management information to key internal and external stakeholders, including the Board, Operating Committee and other Senior Management forums and the regulators
Responsible for entering and tracking of formal remediation actions in the Firm’s regulatory issues tracking system (OpenPages)
Excellent Word and PowerPoint skills and highly proficient in Excel. SharePoint and OpenPages skills an advantage
Skilled in balancing multiple high-priority projects and tasks simultaneously
Willingness to learn and an interest in financial markets and Regulatory environment

Director Head of Regulatory Onboarding Operations Resume Examples & Samples

Facilitate the regulatory onboarding of U.S.GBM clients in an efficient, compliant, and client-centric manner. Resolve day to day matters for the regulatory onboarding operations teams in the U.S.; rapidly triage and escalate complex issues to management for resolution
Play a key role in the development and roll-out of both tactical process changes and long term technology solutions to centralize KYC/AML and other regulatory onboarding requirements in the U.S.. Coordinate and reconcile U.S. on-boarding with Scotiabank global policies and procedures. Provide subject matter expertise in the structuring and rollout of new technology and process changes required to ensure onboarding activities are compliant with regulatory reform impacting the division globally (e.g., Dodd Frank, FATCA, EMIR/MFID, etc.). This involves defining business requirements and processes, assisting in the preparation of business case proposals, and participating in testing. Support the Director, Operations & Technology in
The incumbent must have recognized expertise of current and anticipated regulatory frameworks impacting client onboarding in the US -namely, US KYC/AML, Dodd Frank, and FATCA
A sound understanding of the wholesale banking and capital markets business is necessary, as is a client-centric approach to the role. The incumbent must have broad knowledge of the end-to-end workflows among the Front, Middle, and Back Offices. The international scope of the business, together with the multiplicity of stakeholders, will require work outside of traditional business hours from time to time
Must be able to operate effectively within an exceptionally stressful environment with changing priorities and tight time frames which are closely scrutinized by Senior/Executive Management
The position requires strong business acumen, sound judgment and critical thinking skills. The incumbent must be a developing leader with strong interpersonal, communication and negotiation skills in order to build consensus and obtain co-operation from clients, colleagues, and senior management. Demonstrated team leadership experience is required. in addition, excellent time management and organizational skills are required to allow the incumbent to best manage the day to day deployment of human resources

Executive Director Firm Risk Management Central Regulatory Function Resume Examples & Samples

Oversee the development of FRM policies and procedures, taking into account current regulatory expectations and Firm practices
Initiate and execute various projects related to policy, governance, and regulatory guidance
Coordinate FRM deliverables and presentation materials for regulatory exams and requests, ensuring accuracy and timely delivery
Proactively monitor key upcoming regulatory guidance to assess level of compliance with current practice and identify potential areas of concern
Take a lead role in the Firm’s communication with regulators regarding risk management related issues
Ensure the timely production of reporting for senior management related to regulatory exams and internal audits
Minimum 7 years of experience in consulting, legal or complex financial institution
Excellent verbal and written communication skills, with the ability to communicate with senior management
Proven leadership ability with strong relationship building and client management skills
Intellectual curiosity with a focus on information sharing
Experience interacting with large bank/securities regulators (e.g. FRB, OCC, SEC, PRA, FINRA, CFTC) is a plus

Technology Regulatory Engagement Director Resume Examples & Samples

Driving consistent review and communications processes with global regulators reviewing technology risks and controls, collaborating with the firm's global Legal, Compliance and Technology organizations
Creating and supporting a global “Regulatory Change Management” function that oversees the end-to-end workflow required to identify, classify, analyze, and enact technology controls changes from the global regulatory community that impact the firm
Creating a North America regional Technology Controls Officer (TCO) function to align with other regional and Line of Business-aligned TCOs
Overseeing requests from Legal and Compliance for project support
Developing a “project portfolio” approach to overseeing active and future GTSE work efforts
15+ years of Information Technology Risk and Controls, IT Audit or Information Security preferably with a global financial services institution
Experience directly interfacing with regulators during an examination is required
5+ years of experience in conducting or managing regulatory reviews with internal and external stakeholders
Experience working with both Domestic and International regulators
Strong execution focus, ability to push for progress, confidence to speak up/ push back and know when appropriate to escalate

Director, Global Regulatory Leader, Oncology Resume Examples & Samples

A minimum of Bachelor’s degree is required, preferably in a scientific or technical related disciple. An advanced degree (MS, PhD, MD or Pharm D) is preferred
A minimum of 10 years of experience in a highly regulated environment, such as pharmaceutical, medical device, or consumer industry, with at least 6 years of Regulatory Affairs, Compliance and/or Quality experience is required
A minimum 4 years of experience within a supervisory capacity or managing teams within matrix environment is required
Experience leading interactions with Health Authorities is required
Working knowledge of worldwide Health Authority laws, regulations, guidance and global regulation submission routes available for new study drugs is required
Knowledge of labeling aspects is required
Solid understanding of the Oncology therapeutic area is required
Experience developing regulatory strategies and an understanding of product development is required
This position will be located in Raritan, NJ, Titusville, NJ, Spring House, PA, or High Wycombe, UK, and will require up to 10-20% domestic and international travel

Associate Director, SSU & Regulatory Resume Examples & Samples

Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams
Interacts with the internal or external Legal Departments and assists with the accurate creation and implementation of contract management workflows or with the contract management group. Identifies and reports on areas of process and contract risk
Establishes and maintains training materials for assigned area

Asset Management Regulatory Director Resume Examples & Samples

Assessing compliance risks and controls,
Developing and implementing compliance supervisory and control solutions,
Assisting with the response and/or remediation associated with regulatory actions
Identifying and addressing client needs: developing and sustaining deep client relationships using networking, negotiation and persuasion skills to identify and sell potential new service opportunities; preparing and presenting complex written and verbal materials; and defining resource requirements, project workflow, budgets, billing and collection
Leading teams to generate a vision, establish direction and motivate members, create an atmosphere of trust, leverage diverse views, coach staff, and encourage improvement and innovation

Health Plan Regulatory Services Director Resume Examples & Samples

Personnel Mgmt: Manages the efforts of direct reporting, as well as matrix reporting, positions. Responsible for selecting, developing, deploying personnel in the most effective manner to meet objectives. Responsible for performance Mgmt, compensation decisions, providing on-going, regular developmental feedback. Influences performance Mgmt, compensation decisions, ongoing feedback for individual contributors reporting to direct report Mrgs, possibly through more than one layer of subordinate Mgmt
Communications, Stakeholder Mgmt, Negotiation of Agreement: Facilitates communications, manages relationships w/stakeholders, garners support and agreement from involved parties for compliance initiatives and programs for functional areas across the enterprise
Issue Mgmt, Response, Mitigation: Responsible for issue Mgmt, response, mitigation for functional areas across the enterprise. Proactively identifies risks and issues related to projects production operations. Anticipates and addresses issues through regular communication w/reporting positions and other internal, external parties at all levels, mitigating risk or, in the most severe cases
Minimum five (5) years of management experience
Minimum ten (10) years of progressively-responsible health care administration or regulatory experience
Master's or JD degree preferred

Program Director Commercial Regulatory Resume Examples & Samples

Strategic Agility – Articulates wise, long-term objectives and strategies. Links his/her responsibilities with the mission of the whole organization. Regularly updates plans to reflect changing circumstances. Focuses on activities that provide the most value
Decision Making – Understands the broad context for decisions and reflects that context in how decisions are made. Makes good decisions even in the face of ambiguous circumstances or contradictory requirements. Able to manage divergent perspectives and to deliver difficult or unwelcome information in a constructive and productive manner. Gathers information necessary to make decisions. Thinks through problems clearly and logically. Is decisive; doesn’t procrastinate on decisions. Expresses regulatory position and rationale clearly and fluently. Encourages direct and open discussions about important issues – eliminating churn and driving towards clarity
Inspiring and Influencing - Fosters an exchange of ideas and support amongst colleagues. Is good at promoting an idea or vision: persuading. Works effectively with other people over whom he or she has no direct authority. Understands what motivates other people to perform at their best
Technical and Business Expertise – Has a firm grasp of internal and external conditions affecting the organization. Applies emerging knowledge and trends in one’s area of expertise to improve results. Builds strong relationships with key customers. Contributes expertise to help colleagues within and beyond his or her area

Associate Director, SSU Regulatory Resume Examples & Samples

Oversees and coordinates all functions from a project-specific and a regulatory perspective, including recruitment and career management
Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations
Approves courses of action on salary administration, hiring, corrective action, and terminations
BA/BS in the life sciences, marketing, communications, business administration, related discipline, or equivalent education and experience
Experience working in a contract research organization preferred
Demonstrated Ethics, Regulatory and Site Contracts expertise in strategic planning, design, analysis, and oversight of delivery in clinical studies
Attention to detail, flexibility with excellent organizational, verbal and written communication skills

Regulatory Advertising & Promotion Director Resume Examples & Samples

A minimum of 8 years of experience at a Health Authority, pharmaceutical or biopharmaceutical industry is required
A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Sales, Marketing, Legal, Quality, etc. is required
Knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required
Demonstrated ability with complex problem solving; excellent written and verbal communications required
Proven track record in delivering results, self-starter and ability to manage complexity and deals well with ambiguity and new areas
Must be able to be based in Titusville, NJ and travel overnight occasionally (approximately 10% annually).Health Care Compliance

Audit & Regulatory Director Resume Examples & Samples

Primary contact for executives and senior management, providing guidance and advice related to Information & Technology Risk controls ensuring effective due diligence to facilitate awareness and mitigation of potential areas of risk
Develop, implement, and operationalize the Control Framework and Stakeholder Engagement Model related to information and technology controls relevant for Lines of Business and suppliers
Ensure Lines of Business units and suppliers adhere to control objectives that are specified in the Bank, by the Shareholders Audits, Corporate Audit Division, and applicable regulatory requirements (e.g. SOX, PCI, SOC)
Define, operate, and test/substantiate controls across the Bank’s 17 risk categories within GI&TRM
Structure the controls function and supporting processes for GI&TRM
Participate and contribute at management team level in business and strategic planning. Represent Risk and Controls interest in that forum and interpret information in the context of own business
Build partnership with internal clients and other business stakeholders; build relationships with internal and external auditors and regulators; build relationships and network with counterparts at competitive financial institutions and manage external clients when necessary
Establish a culture and work environment that attracts, retains and motivates a diverse, skilled workforce in order to maintain a high degree of employee professionalism, commitment and desire to maintain updated skills and knowledge in support of a high performance culture
Provides leadership and direction by setting context, defining accountabilities, tasks and assignments
Coaches, motivates, develops and evaluates performance of direct reports and provides guidance and mentoring in the resolution of complex issues
Provides development opportunities to direct reports, including the identification of training needs, creation and implementation of appropriate development plans, monitoring, documenting and providing regular feedback on performance
Strong collaboration and communication skills
10+ years of experience in IT audit, information security audit or related field; 15+ years overall industry experience
Financial industry experience preferred; Previous experience of interaction with regulators preferred
Previous experience with application development, infrastructure and architecture
CISA, CISSP or other related professional security certifications
Possesses a university degree/college diploma in Information or Technology Management or Risk Management or equivalent work experience
Demonstrate a comprehensive understanding of how areas of IT and IS controls collectively integrate to contribute to achieving business goals (good industry knowledge is expected)
In-depth expertise in relationship management, to be able to create inclusive strategy
Ability to implement security strategies and standards
Experience with a broad range of exposure to all aspects of systems analysis, application development, infrastructure, architecture and information security
Information technology/security subject matter expert on technical solutions, standards, process, procedures, compliance, risk and awareness
Possesses detailed knowledge of financial industry regulatory environment and risk management practices, and thorough understanding of local and federal regulations
Ability to operate effectively in a matrix environment

Global Program Regulatory Director Resume Examples & Samples

Provide regulatory leadership to assigned project(s)
Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans
Ensure that Regional/Country Pharma Organization (CPO) input is sought and incorporated into global regulatory strategy
Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks
Responsible for development and implementation of the Regulatory Seed Document/Regulatory Functional Plan
Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of key program changes/information to support appropriate, timely communication to Health Authorities globally
Partner with regions to align on regulatory strategy in order to fullfill business objectives
Obtain timely consultation with Drug Regulatory Affairs (DRA) line management and Novartis advisory boards on regulatory strategy
Lead interactions with regulatory consultants/advisors for strategic input and challenge
Represent DRA on the GPTs and communicates key program information to regulatory team members and DRA management
Provide strategic input to GPT and DRA team on key Health Authorities (HA) documents, obtaining appropriate line endorsement as appropriate
Provide strategic input, review and approve clinical study protocols and protocol amendments
Lead DRA activities regarding Novartis safety risk communications for the assigned projects
Provide strategic regulatory input into BD&L Due Diligence evaluations as required
Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas: -Innovation in regulatory strategy
Prior history with post-marketing/brand optimization strategies and commercial awareness
Major involvement in a CTD/MAA/NDA submission and approval
Leadership role in HA negotiations in multiple regions
Proven success in global drug regulatory submissions
Proven ability to analyze and interpret efficacy and safety data
Regulatory operational expertise
Minimum 2-5 years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry
Global matrix management people management experience desirable
Good management, interpersonal, communication, negotiation and problem solving skills
Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working crossfunctionally

Senior Director of Regulatory Surveillance Resume Examples & Samples

Oversees post-trade and real-time surveillance for Nasdaq options and equity markets
Oversees the Philadelphia based surveillance analyst team with a current focus on post trade surveillance of Nasdaq’s six options
Strong conceptual knowledge of the options and equity market industry
Strong understanding of Nasdaq options rules and regulations
Develop, implement and oversee new surveillance patterns and enhancements to detect potential market abuse
Coordinate investigations with other SROs and regulatory organizations relating to rules and regulations
Interprets referrals regarding suspected market abuse and disciplinary matters, determining proper course of action
Leads initiatives that form market practice for the exchanges and the securities industry, ensuring business enhancement and alignment with strategy
Evaluates markets to detect anomalies, review electronically generated alerts, and address market participant inquires
Guides the use of techniques to keep the markets fair, orderly, and efficient through implementation of a comprehensive web of regulatory surveillance scrutiny and action
Provides leadership and direction through team members
Takes accountability for the performance and results of related teams and disciplines
Evaluates current business processes and systems, driving cost-savings and risk control
Ensures all work in business unit is compliant with regulatory and corporate guidelines
Coaches and inspires lower level managers to achieve better performance
Motivates, develops, recruits and retains employees while rewarding and cultivating a culture of high performing teams

Director, Global Regulatory Intelligence Resume Examples & Samples

Represent Global Regulatory Policy & Intelligence and GRA on internal and external forums / networks as assigned. Provides impactful summaries and strategic advice, back to the business, regarding assigned internal / external activities. Positively influence the regulatory environment as needed, to meet business needs
Oversee GRA participation in regional committees to drive effective networking and representation to ensure a one voice policy
Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may bear influence to Takeda and propose action plan
Play a key role in development and implementation of appropriate systems, processes and standards within Regulatory Policy & Intelligence within GRA and across Takeda as assigned
Work closely and partner with a number of subject matter experts to plan regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest. This includes to liaise closely with colleagues (R&D, Policy, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment on Takeda position
Provide leadership for specific external engagement and / or Regulatory Policy activities, as assigned. In collaboration with Subject matter Experts and/or Therapy Area Regulatory leads develop focused analytical responses to therapy area and regional procedural queries
Contribute to or has primary responsibility for the management and maintenance of special projects such as Global Regulatory Affairs Priority Topic list, position papers, and regulatory issues/trends reports, as assigned
Work with external parties/consultants as appropriate to define messaging approach and strategy
Ensures regular RI updates to provide education, knowledge sharing, newsletters, reports and other modes of communication to advance regulatory expertise and decision making for the region
Maintain consistent oversight of deliverables. Keep all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level
Lead routine and ad hoc meetings within function and cross-functionally. Presents to senior management as relevant
Manages personnel within group to ensure coverage for regional responsibilities; Elevates needs when necessary
BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases
Deep understanding of regulations and guidances governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role), with a good understanding of basic regulatory requirements in emerging markets. Sound knowledge of intelligence tools and methods
Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region. Proven track record working with a major regulatory agency, specific experience in government affairs or policy is also desired
Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Proven success at stakeholder engagement across organizational levels and boundaries
Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
Ability to develop regulatory strategy to balance short and long term objectives, and drive teams to make decisions and achieve deliverables within agreed parameters and timescales
Generally strong in working well with others, within global teams and communicating with senior leadership
Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff
Experience in managing personnel required; experience managing relationships with CROs and/or contractors also preferred

Regulatory Intelligence Director Resume Examples & Samples

Master degree or equivalent level is strongly recommended (science or technology is preferred)
At least 10 years experience in pharma industry preferably including experience in a regulatory intelligence role
Skilled networker
At least 6 years experience managing people and/or teams including developing direct reports
Proven innovation skills
Ability to multi-task across multiple projects and deliverables
High integrity to maintain confidential and proprietary information

Director of Quality & Safety Regulatory Resume Examples & Samples

The daily management of the hospital quality and patient safety team, including risk, infection control, patient advocacy, and performance improvement
Works closely with local leadership and leadership at the Corporate level to assure alignment of standard work, implementation of best practices, and a culture of safety in a learning organization
Coordinates the regulatory compliance program to meet the standards identified by the JCAHO, DPH and CMS, including the National Patient Safety Goals. Support project structure to insure all staff is involved in regulatory readiness on a daily basis including racer rounds with defined tools and processes that include feedback from the patient and/or family rounds with senior leadership, and other unit/service specific tracers. Communicates findings and follows up or adjusts as applicable
Works with administrative and clinical leadership to insure they recognize their role in preparation for regulatory readiness. Is supported by the hospital leadership in assuring this process is hospital wide
Is knowledgeable of all standards specific to the Joint Commission, CMS, DPH, OSHA, FDA, etc
Is knowledgeable and versed in the completion of the annual Periodic Performance Review including identification of hospital vulnerabilities that require changes to ensure ongoing survey readiness
Prepares reports, tracks responses, and coordinates communication regarding quality and safety issues to external regulatory agencies
Works on a team to recommend and facilitate sustainability efforts to improve quality and patient safety, based on identified risks and hospital data. Regularly reviews the sustainability educational program relevance, participation, and effectiveness , and adjusts as needed
Serves as liaison between Hospital Leadership and the system level regulatory groups to aggregate data and make recommendations on matters that affect compliance with quality and patient safety standards
In coordination with the Sr. Director of Quality and Safety (Corporate level) and the Risk Manager manages all survey activities from arrival, coordination of survey activities to exit exercises inclusive of successful completion of any action plan associated with the survey process to ensure ongoing accreditation
In coordination with Risk Management personnel, investigates patient safety failures and issues within the system, participates in Root Cause Analysis of internal error reports and critical event reviews
Serves as a resource for departments on issues of patient safety and regulatory compliance
Serves as the lead, co-lead, or team advisor for performance improvement projects related to publicly reported clinical measures, developing and executing complete project plans to include budgets and schedules, and plays a lead role in fostering the effective implementation of desired changes. Areas of attention will include, but not limited to, publicly reported data, such as Joint Commission CORE, MassP$P, CMS and other measures as determined by public reporting
Designs measure to evaluate the impact of interventions on publicly reported measures. Works with the Corporate analytics team identify trends, and highlights opportunities to improve performance
Directs and supervises assigned personnel including performance evaluations, scheduling, orientation, and training. Make recommendations on employee hires, transfers, promotion, salary changes, discipline, terminations, and similar actions. Resolves grievances and other personnel problems within position responsibilities
Develops and recommends the budges for the areas managed. Management activities to assure financial goals are met
Coordinates the assignment of tasks and helps resolve technical and operational problems. Evaluates the impact of solutions to ensure goals are achieved
Provides effective direction, guidance, and leadership over the staff for effective teamwork and motivation, and fosters the effective integration of efforts with system-wide initiatives
Participates in performance improvement initiatives and demonstrates the use of quality improvement in daily operations
Develops and maintains policies and procedures necessary to meeting regulatory requirements
Ensures that department complies with hospital-established policies, quality assurance programs, safety, and infection control policies and procedures
Ensures adequate equipment and supplies for department
Develops and maintains established departmental policies, procedures, and objectives
Ensures compliance to all health and safety regulations and requirements
Performs similar or related duties as required or directed
Master's degree in public health, nursing, health care administration, business administration or related area, with five years related experience, is required. RN degree preferred. Lean certification preferred. In depth experience with risk management principles, patient safety science, publicly reported quality measures, operations analysis, and quality management – performance improvement methods required
Excellent communication skills accompanies by the ability to analyze and present data to influence behavior, stimulate innovation, promote best practices, and drive organizational change
A highly skilled change agent with demonstrable sensitivity to the interpersonal, group dynamic, organizational, political, and perceptual issues associated with change
Results orientation accompanied by the skill set required to conceptualize, implement, and operationalize a user-friendly clinical excellence and patient safety program
Demonstrated ability to create and sustain momentum through relationship building, and collaborative management
Ability to effectively utilize a variety of computerized software applications such a spreadsheet, work processing, relational database, and graphics software packages required

Finance & Risk-regulatory & Compliance Principal Director Resume Examples & Samples

Requires proactive identification, definition and solving of complex problems that have impact on the direction of the business or work effort, where analysis of situations requires an in-depth knowledge of Accenture
Requires development and execution of strategy to achieve key business objectives in area of responsibility
Interaction is with senior management levels at a client and/or within Accenture, involving negotiation or influencing on critical matters
Wide latitude in decision-making and determination of objectives and approaches to critical assignments
Decisions have a major and lasting impact on areas outside of own responsibility
Manages large complex teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
Architect and deliver consulting solutions and services and provide sales support within a clearly defined area of industry expertise that is supported by the business
Add credibility to Accenture's reputation during the sales process and deep expertise through delivery phase
Contribute to and lead asset/offering development and thought leadership activities through points of view, Knowledge Exchange, discussion boards, etc
Contribute to the design and execution of the practice’s growth plan; support the go-to-market strategy, offering prioritization, design and planning
Develop trusted relationships with internal and external clients, and have an eye for qualifying potential opportunities and/or negotiating complex deals
Build strong relationships with global Accenture Regulatory & Compliance teams, and further develop existing relationships based on mutual benefit and synergies
Participate in and bring capability expertise to the client account planning process
Lead small-to-large client delivery engagement teams to architect, design and deliver consulting services that deliver agreed business outcomes for our clients
Lead and/or act as a key player in other critical situations within area of expertise, either internally or at client engagement(s)
Formally act as a mentor or coach to junior people to help grow the next generation of experts
Lead other practice-building activities (e.g. professional communities; teaching) in area of expertise
Understand and translate customer needs into implementable business solutions to enable long-term success and business integration
Drive and understand analysis of the as-is and to-be processes
Lead the design of new business processes based on customer requirements and conduct user review sessions and run stakeholder agreement meetings
Build and maintain strong connections with the external professional community in their area of expertise (and may be sought out for their opinions, publishing and speaking at clients or forums in the industry)
Implement process and change interventions
Lead implementation of programs/interventions that prepare the organization for implementation of new business processes
Accountable for program execution or deliverable using planning, communication and training skills
Bachelor’s Degree. An Advanced Degree and/or M.B.A. is highly desirable
Minimum 15 years of Regulatory or Compliance experience within the Financial Services industry spanning Capital Markets, Banking and/or Insurance (e.g., Regulatory agencies, senior Regulatory Relations and/or senior Compliance positions within Financial Services organizations, investigators or related agencies with deep surveillance or intelligence experience, etc.)
Deep experience with Compliance and/or Regulatory Change topics within the Banking, Capital Markets, and/or Insurance industries or experience as a regulator either in an examiner, rule and policy development or enforcement capacity
Strong understanding of front and back office operations
Familiarity with Risk and/or Compliance technology vendors in your domain area a plus, particularly Surveillance applications
Demonstrated client and other stakeholder management skills
Experience with FS Risk Operating models and/or Compliance Standards
Understanding of Compliance processes and Compliance regulatory requirements
Experience publishing research and/or presenting ideas at industry conferences and seminars
Demonstrated track record of creativity and innovation
Prior experience within a top management consulting firm focused on the Financial Services industry, including: demonstrated understanding of project management, project economics and client relationship management is highly desirable
Experience of working with clients on development of business and technology solutions to business problems arising from Misconduct including business, market and sales practice related issues within the Financial services industry
Experience building out conduct risk programs and development of KRI’s/KPI’s and MI reporting
Understanding of culture and ethics and behaviors driving organizational culture within the FS industry
Understanding of surveillance technologies and solutions across market, e communications, trade and voice
Understanding of analytics and risk models that can support conduct analysis and reporting
Demonstrated team management and leadership skills, including a proven ability to build, manage, and foster a team-oriented environment
Demonstrated ability to facilitate senior client meetings and drive conversations at the executive level, including the ability to convey technology and business value propositions
Demonstrated ability to interface effectively with clients individually and as a member of an engagement team
Demonstrated ability to understand client needs, develop proposed solutions and deliver high impact change initiatives
Ability to articulate and clearly communicate the solution scope, timeline and benefits with clients
Ability to communicate tough messages in a professional manner to clients and recommend innovative solutions
Experience eliciting high-level business requirements and creating detailed functional specs as well as other documentation, such as requirement traceability matrices, work-flow diagrams and use-cases
Ability to develop strong working relationships with all relevant parties, particularly at the senior management level
Attention to detail while managing competing priorities and tight time pressures
Strong analytical, problem solving and troubleshooting skills with the ability to exercise mature judgment
Demonstrated delivery and change management experience
Desire to lead and motivate teams in dynamic and challenging work environments
Results-oriented, self-directed, inquisitive, and entrepreneurial-minded

Eemea Regional Regulatory CMC Leads Associate Director Resume Examples & Samples

For assigned product portfolio, EU/EEMEA RA CMC Leads will have primary responsibility to develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice and post-approval changes
Working collaboratively with Global CMC RA Product Leads, the Regional RA CMC Leads will ensure right first time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the lifecycle
Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Therapeutic Area portfolio, commercial and operational strategies and the Target Product Profile issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management
Support MSD Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert). Director/Associate Director roles will have direct interaction with Health Authorities. Subject Matter Expert - SME)
Act as Regulatory CMC SME in post approval requirements and maintain/update the regulatory intelligence repository for Regional markets including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first time submissions
Ensure high quality and timely responses to Regulatory Agency questions in Regional markets and fulfillment of regulatory commitments to Regulatory Agency deadlines
Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details
Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice
Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business
Bachelor’s or Master’s Degree in a chemistry, pharmacy, biology or related science
At least five (5) years of relevant regulatory CMC experience (covering at least one sub-region of the EU/EE/ME/A countries) for Senior Specialist, at least seven (7) for Associate Director and at least 10 years for Director positions. Senior positions are likely to also have additional prior experience in the pharmaceutical/device industry including manufacturing, testing, research; or licensure of products
Direct regulatory CMC experience in development and registration of biologic/biotechnology products or vaccines is required for Director and Associate Director positions. Direct Health Authority experience would be an advantage
Some Associate Director/Director roles may require management responsibility for a small team of Regulatory (Senior) Specialists
Knowledge of current ICH and local Regulatory Agency legislation and guidance and current hot topics related to pharmaceutical, biological and/or vaccine products
Ability to communicate effectively in English (written and verbally proficient)
Ability to influence and a keen eye for detail
Ability to work well under pressure either independently or collaboratively in a team

Associate Director, SSU & Regulatory Resume Examples & Samples

Degree educated or equivalent in a science or healthcare field
Direct experience making CA submissions across multiple countries
Excellent understanding and experience in Regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release requirements in multiple European countries

Director of Risk Management & Regulatory Compliance Resume Examples & Samples

Experience:Management experience preferred to include at least 2-3 years of risk management and regulatory compliance experience
Education:Bachelor's Degree required, Master's degree in healthcare related field preferred
Special Qualifications:Must possess strong computer skills, excellent interpersonal, written and oral communication skills and the ability to prioritize responsibilities and manage multiple simultaneous projects as well as strong knowledge of Joint Commission and CMS regulations and compliance

Director of Finance Pending Regulatory Approval Resume Examples & Samples

Serves as a leader for employees while fostering teamwork, employee morale, motivation and open communication
Provides direction and support for all staff to achieve Company goals and objectives through the fair and consistent application of policies and procedures
Endorses the business objectives, ethics and values of the company
Provides appropriate recognition and rewards to individuals and groups when consistent superior performance is attained
Provides direct supervision of financial reporting, income control, accounts payable, accounts receivable and payroll
Responsible for the preparation of the capital and operating plans and in the evaluation of the results of the operations
Responsible for all capital expenditure approval, cost tracking and reporting
Provides assessments of economic impact of proposed transactions
Bachelor’s degree (B.A./B.S.) from an accredited four-year college or university
Must be proficient in Microsoft applications (Excel, Access, Word)
Six years minimum performing accounting and financial analysis
Must possess strong verbal and written communication, managerial and organizational skills

Director of Regulatory Compliance & Safety Resume Examples & Samples

Dealing with complexity
Requirements analysis
Operations research
Developing standards
Legal compliance
Technical leadership
Quality management and strategy

Regulatory Director Resume Examples & Samples

MS / PhD in Food Science, Chemistry, Biochemistry of other related science discipline or 16+ years of experience (education & work combined) as functional leader for a global food business or related industry
Strong background in interpreting and applying regulatory standards and influencing regulatory changes through association and governmental interactions
Proven experience in process management systems
Ability to lead and influence cross-functional teams at multi levels within the organization
Excellent Interpersonal, communication, coaching and conflict management skills
Proven track record of driving continuous improvement and change management initiatives
Expert observation, analysis and judgement (i.e. analytical and objective mind-set)
Direct Customer Management experience essential

Director, Global Regulatory Sciences Strategy Resume Examples & Samples

Integrates the European regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives
Translates strategy into operational goals and objectives, identifies resources and leads to organization to focus on objectives. Assures that the organization follows through to achieve high quality execution of plans
Ability to contribute and add value to the writing of scientific documents for regulatory purpose
Executes negotiations with EMA in line with BMS strategy and provides strategic directions and supervises negotiations with other relevant regulatory agencies for assigned project
Provides direction for maximizing opportunities within projects (e.g. life-cycle) and across the geographical area to support the productivity priorities
Participates actively in and represents Global Regulatory Sciences for their project on various multi-functional committees or teams (e.g., Brand Team, Regional Operating Committee, if applicable)
Communicates actively and timely with Global Regulatory Sciences colleagues in European countries, including through direction of European Regulatory Teams
Active participation in regional organizational activities for the Liaison function (across projects)
Develops strong working relationships with key stakeholders both within and outside the company
Builds and maintains strong relationships with alliance partners when applicable
Watches, anticipates and acts on trends and changes in the European and international regulatory environment which may have an impact on the business
Conducted prior negotiations with regulatory authorities
Contributed to scientific documents developed for regulatory purposes
Established credibility and respect during previous exposure with regulatory authorities and peers
Demonstrated ability to react appropriately in difficult, possibly adverse, conditions and/or in crisis situations
Demonstrated ability to integrate regulatory, scientific/medical and business perspectives and to translate this analysis into practical recommendations and operational goals
Developed working relationships and/or built a team resulting in a performant network or organization
Demonstrated values, behaviors, professional standards and cultural sensitivity compatible with BMS vision and culture
Strong scientific/medical background preferred
Understanding of pharmaceutical product development
Understanding of EU regulatory principles and their impact on company's development and business
Understanding of the complexities of cross functional management issues
Understanding of legal and business aspects related to EU regulatory procedures and outcomes

Director of Global Regulatory & Clinical Safety Procurement Resume Examples & Samples

Minimum of ten (10) years’ experience in Drug Development in the Pharmaceutical Industry with a consistent history of delivery in roles such as, but not limited to, regulatory affairs, clinical safety, clinical research, financial planning, procurement and/or supply chain management
Significant experience in managing sponsor/supplier interactions in roles such as, but not limited to, business development, project management, contract management, or relationship management
Line Management experience of internal associates, or management of individuals externally to deliver clinical development pipeline associated activities
Detailed understanding of the Regulatory, PV and CMC processes to support getting product on the market and maintaining products on the market. Superior analytical skills in evaluating complex Regulatory, PV and CMC business requirements, supplier bids and internal benchmarking data
Sourcing Management Process: Demonstrated expertise in executing the Sourcing Management process across highly complex projects, ability to complete projects on time and within budget
Excellent and proven business partnering skills

Regulatory Director Resume Examples & Samples

CUSTOMER & BUSINESS SUPPORT
POLICIES & PROCEDURES
Team Management
PhD in Food Science, Chemistry, Biochemistry or other related science discipline or 16+ years experience (education & work combined) as functional leader for a global food business or related industry

Global Program Regulatory Director Resume Examples & Samples

Medical Device experience (EU / Row)
OTC and US Product Monograph (21CFR349)
Strong global ad/promo review
Early and full development regulatory affairs experience with global exposure

Associate Director, Global Regulatory Lead Resume Examples & Samples

25% Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations. Single point of contact and accountability for regulatory and leads the regulatory subteams as well as represents regulatory on key internal decision making teams such as PSTs and GDTs
25% Functions as the global regulatory lead for assigned projects, working with a cross-departmental group of regulators as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and Intel/Policy to drive global regulatory strategies
Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects
25% Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings
5% Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image
Effectively leads key meetings with HAs to ensure full discussion of issues and opportunities
5% Provides guidance to all appropriate departments in Shire to assure compliance with applicable regulations
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate
Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed
5% Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Shire staff
5% Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed
5% May supervise a changing number of Regulatory Affairs Associates
Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Shire staff
BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience
Generally has at least 5-10 years of Regulatory Affairs or equivalent experience. The regulatory experience should be broad to ensure appropriate leadership and mentoring for regulatory staff within Shire

Regulatory & Compliance Advisory Managing Director Resume Examples & Samples

Fifteen (15) or more years of experience in consulting related to regulatory and compliance issues, AML, and/or financial advisory services
Prior experience acquiring, training and mentoring consulting professionals required
Participation within professional associations required
Strong leadership skills with the ability to thoughtfully and positively influence, negotiate and manage change
Capacity to successfully manage and secure sales of consulting services to the banking and capital markets sector
Ability to develop and maintain a diverse network of referral sources to include financial institutions, private equity firms, hedge funds and law firms
Ability to work in a deadline-driven environment and handle multiple projects simultaneously
Capable of effective managing a team of consulting professionals and delegating work assignments as needed
Capacity to build and maintain strong relationships with internal and client personnel
Ability to encourage team environment on engagements and contribute to the professional development of assigned personnel
Executive presence and ability to act as primary contact on assigned engagements
Ability to successfully interact, develop and maintain relationships with professionals at all levels both internal and external to the organization

Risk & Regulatory Director Resume Examples & Samples

Monte Carlo Simulations, research and development of risk management models involving market risk, credit risk, operational risk, economic capital areas and of capital markets and counterparty risk management
Risk scenario analysis on complex products to assist engagement teams as they measure and manage key risk exposures for their clients, including performing analysis and testing on new pricing models and new yield curves across all applicable trading products
Financial Derivatives, including Credit Derivatives
Researching and utilizing numerical methods and stochastic modeling
Prepayment, credit risk, fair lending, default, Basel or fair lending modeling/modeling validation
Advanced statistical and/or econometric modeling techniques and complex Excel-based spreadsheet models
Statistical modeling assessing strengths and weaknesses
Commercial lending products and processes such as commercial & industrial loans, commercial real estate, asset based lending, project finance, leasing, etc
Economic capital and loan pricing fundamentals

Senior Regulatory Program Director Resume Examples & Samples

Primary contact for regulatory compliance topics and projects within Pharma Technical Regulatory Small Molecules (PTR SM)
Represent Pharma Technical Regulatory in or lead internal and global cross-functional compliance projects and initiatives to drive the implementation and development of Roche/Genentech’s Pharma Quality System or to develop solutions for emerging new regulations impacting compliance aspects or regulatory operations
Responsible for developing, implementing and overseeing regulatory compliance check processes for major regulatory dossiers submitted by Roche/Genentech globally, develop templates and metrics to monitor the process and help optimize the key deliverables, i.e., accuracy of dossiers against plant practices, quality of dossiers and turn around time of compliance checks
Monitor regulatory commitments made by Roche/Genentech and assure commitments are being fulfilled on schedule, and develop an adequate and timely reporting for senior management and stakeholders. Implement ways to optimize and improve the management of the commitment tracking and delivery, across marketed and development projects
Lead or support compliance audits at PTR and of PTR processes (regulatory change assessment, TRIC, APQR, etc.), lead and coordinate audit response teams and take ownership for audit observations closure
Act as Business Process Owner for PTR Lifecycle Management processes
Support and Sponsor regulatory aspects of Technical Change Management processes
Own Service Level Agreements related to regulatory compliance activities (e.g. APQR); ensure consistent and reliable supply of regulatory information
Coordinate PQS activities for Technical Regulatory (Doc reviews, impact assessments)
Collaborate across PTR platforms and drive for convergence to improve alignment, efficiency and simplification
Primary PTR Small Molecule contact for all aspects of issue management and issue resolution internally and with agencies (particularly FDA)
Represent PTR in Global Expert Groups (GEGs) and other issue resolution forums
Develop NDA-Field Alert Report (FAR) strategies & recommendations. Provide the regulatory compliance feedback at GEGs. Lead and co-ordinate efforts to file Field Alert Reports (FAR) and notify FDA in such cases. Lead response teams to make sure that the issue is resolved in a timely manner
Chair and lead US Field Action Committee (FAC) and Local Expert Group (LEG) meetings to manage regulatory compliance issues and oversee field actions
Develop and manage Product Recall activities ensuring compliance with FDA requirements
Provide regulatory oversight and strategic input for discrepancy management and to inspection response teams
Collaborate with Global Quality, Regulatory Affairs, Safety and Medical, Commercial, etc. to champion risk based assessments of compliance issues and develop appropriate regulatory recommendations/actions
Lead FDA meetings/activities with FDA’s CDER and/or local district offices on Drug Shortages, Counterfeits and other technical regulatory compliance issues on behalf of Genentech/Roche
Collaborate with all stakeholders to continuously improve processes and clarify decision making around regulatory compliance topics

Director of Regulatory Planning Resume Examples & Samples

Master's Degree in Healthcare Management, Business Administration, Public Administration or equivalent
Minimum of 8-10 years of healthcare, hospital regulatory, strategic planning and/or healthcare planning consulting experience
Excellent analytical and technical planning skills required addressing highly complex planning issues
Proficiency in word processing, database, spreadsheet, and presentation development

Director Legislative & Regulatory Affairs Resume Examples & Samples

Five (5) years’ experience in position requiring high levels of cooperation, collaboration, and management of staff
Minimum of three (3) years' experience in a leadership role, ideally leading and implementing a comprehensive compliance program
Experience conducting research, thorough analysis, and interpretation of findings
Strong leadership and management skills
Experience leading audits and major program initiatives
Experience maintaining effective working relationships with regulatory agencies. Thorough understanding of health services, health care delivery models, health care benefits and regulations
Ability to effectively interpret government contracts to ensure compliance. Demonstrated ability to supervise, motivate and coach staff

Director, Quality & Regulatory Compliance Resume Examples & Samples

Provide leadership and guidance in the timely communication and escalation to the Staff VP, QRC of site issues associated with regulatory compliance/audits findings
Provide management and oversight of the Corporate QRC audit function and staff to assure effective implementation of the Corporate audit program
Establish and implement the annual Corporate audit schedule and manage audit activities and resources within the established budget
Provide guidance and direction to Division and manufacturing facilities in the development of corrective action plans and evaluation of effectiveness assessments
As required, support management in the development of quarterly and annual audit metrics and summaries for distribution to key Divisional and manufacturing facility management. Identify and communicate systemic issues to management for further comprehensive action
Conduct directed audits as assigned to assure compliance with commitments to FDA, prepare for anticipated regulatory inspections and to meet other unique audit requests such as due diligence
Partner with the Divisions and sites to establish applicable inspection readiness strategies that consider the external regulatory environment and provide support as required during external inspections
Promote a high degree of professional development of Corporate audit staff through a combination of coaching, internal and external training. Provide auditor training through formal classroom, web-based, and on-the-job training to ensure auditors are highly skilled and there is a consistent focus on areas of greatest compliance interest
Set goals for performance objectives, conduct career planning and administer performance reviews for staff
Develop and implement strategies to better and more efficiently assess compliance risk at Divisions and manufacturing facilities
Develop and implement audit reporting metrics to keep management informed of the effectiveness of Divisions and manufacturing facilities in the resolution of audit compliance issues. Prepare quarterly and annual audit summaries for review with Corporate, Division and manufacturing facility management. Maintain comprehensive knowledge of applicable regulatory authority quality and regulatory requirements and their interpretation. Provide regulatory compliance expertise to the Divisions and sites by sharing external regulatory environment and industry trends
Chairs the Corporate Compliance Council to keep the organization abreast of compliance initiatives
Assist with other assignments and responsibilities as directed by the Staff VP, QRC
Extensive experience implementing and interpreting the FDA regulations for medical devices, pharmaceuticals and combination products
Demonstrated ability to direct and provide advice on the use of quality system design methodologies and tools to investigate and determine root cause, assess compliance risk and establish comprehensive and effective actions plans
Effective project management, communication and organizational skills are essential
Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style
Certified Quality Auditor is a must have (e.g. ASQ CQA, or equivalent certification)
Combination product and/or pharmaceutical experience preferred
B.S. degree in Engineering or the Physical or Biological Sciences
10+ years’ quality, compliance and regulatory experience in the medical device industry
5+ years’ managing an audit program and conducting audits in the medical device or drug industry
5+ years’ experience managing direct and indirect reports

Data Governance Regulatory Director Resume Examples & Samples

Produce and lead governance forums to guarantee standards, policies and processes are effective and producing wanted outcomes
Stay up-to-date and informed on emerging practices for improving data governance practices
Advance framework, metrics and reporting to guarantee progress can be measured, evaluated and continually enhanced
(6) Six or more years of experience in data governance strategy, planning, and/or policy
Ability to navigate organizational restrictions to gain support, build credibility and break down walls
Comprehensive experience in producing, driving and leading enterprise level data governance labors
Results motivated and sets aggressive goals and is answerable for unceasingly driving improved outcomes, leading change and guaranteeing high standards
A trusted partner with experiencing creating alliances and builds trusted associations with peers across technology and the stakeholder
Cooperates across multi-functional teams to drive answerability, progress quality and change-behaviors

Data Governance Lead Regulatory Director Resume Examples & Samples

Recruit, construct and lead a high performing data governance & quality operational team
Create workflow for meta-data review and approval including business term formation, domain creation, assignment of owners and agents, etc
Launch standards for data necessary to be captured to enable governance of business terms, fields, ownership and stewardship
Bachelor’s degree required and Master’s degree a plus
Proven understanding of Master Data Management processes and policies is highly desired
Proficiency with Excel, Access and MSSQL is desired
5 (Five) or more years financial industry experience with relevant experience working either directly in a data management, regulatory reporting or operational project team is preferred
Working knowledge of data governance, data quality and data lineage concepts are compulsory

Regulatory Incentive Program Director Resume Examples & Samples

Partners with reimbursement services and managed care to continually monitor and analyze financial reimbursement trends and healthcare changes within the national market place. Analyzes the national market place as they relate to provider incentive programs. Evaluates the impact to Banner Health and works collaboratively with key stakeholders to determine the appropriate approach related to Meaningful Use (MU)
Collaborates with key stakeholders to establish workflows and processes for strong reimbursement or decreased penalties with operational, clinical and financial leadership. Ensures clear accountability for success, optimizing maximum incentives and minimizes penalties
Partners with educational and communication stakeholders across the system to communicate initial decision, workflows, and processes along with initial and ongoing education for employees, providers and leadership
Oversees the BH EH performance on metrics tied to incentive programs. Creates and implements appropriate action plans to meet targets, as needed
Assists reimbursement services with the submission of results to the appropriate governmental agencies. This includes coordinating and overseeing the distribution of the funds/disincentives with operational and financial leadership

Director, Government & Regulatory Affairs Resume Examples & Samples

Develops and oversees execution by Government Affairs team of local, state and federal legislative strategic initiatives and other public policy strategies. Oversees management of relationships with local franchise authorities, state and local elected officials and other public opinion leaders to maintain the company's positive image
Promotes and advances the interests of the company through grass-roots campaigns and other advocacy at the local, state and federal levels to shape and advance emerging issues that enable Cox to operate in its markets without undue legislation, regulation, taxation, restrictions or other barriers to achieving company goals
Provides analytical review of legislation, ordinances and other legal documents to validate business impact, including identifying potential liabilities and opportunities, including coordination with internal and external partners, including state legislative support and collaboration with Cox Automotive leaders
Ability to review, negotiate and draft/edit complex agreements with governmental agencies and third parties, such as franchise agreements and renewals, right-of-way agreements, settlement agreements; proposed legislation and municipal ordinances; and various company filings with governmental agencies
Leads video franchise efforts in coordination and collaboration with Cox Law & Policy teams, and is aware of applicable communications laws and regulations as well as applicable Federal Communications Commission and state Utilities Commission regulations
Continually evaluates results of government relations activities and adjusts activities to meet changing local conditions
Coaches Cox leadership on tactics for maintaining good relationships with public entities and appearances before legislators. Ensures that the company’s activities and priorities are perceived in a positive light and that the company’s interests are fully and accurately advocated
Collaborates closely with Marketing, Sales, Cox Media, Cox Business, and other departments to ensure alignment of strategies and initiatives for maximum benefit and ROI, and also to maximize business development opportunities
Oversee activities of Government Affairs team and collaborates with key boundary partners such as Public Relations/Communications and/or Community Relations to support business growth and key initiatives
May oversee programs that create a positive company image as a strong community partner aligning government with community relations
Hires, develops, trains and manages Government Affairs team. Motivates and coaches staff to achieve department and company goals
Disseminates company goals and direction to Government Affairs team. Works with team on development of individual team members’ goals and objectives in support of company and individual professional goals
Performs high level budget responsibility and long-term strategic planning
Directs the development of strategic plans for department. Translates strategies for function into short-term objectives and oversees implementation of tactical plans
Drives alignment and consistency in people practices, management activities, and customer service delivery in an effort to achieve goals
Develops policies and procedures for department to standardize practices
Analyzes market trends; coordinates and communicates with others to determine appropriate responses
Establishes and leverages strong partnerships with internal/external customers
Provides strategic direction on political donation program and PAC giving
Travels to South Orange County, Santa Barbara, Sacramento, Washington DC, Atlanta and other locations as needed
Maintains board and leadership roles in community, including regular attendance at events outside business hours
BS/BA in related discipline required
Advanced degree such as MBA, MPA or J.D. preferred
10+ years of experience in Government Affairs or a related field required, including several years in a management/supervisory capacity with an emphasis on leadership and strategy. Related fields might include someone who has worked in an elected office, as a lobbyist, or in public policy
Existing relationships with local and state elected officials, city staff and community leaders strongly preferred
Knowledge of jurisdictional land use permitting processes and staff desired
Able to travel up to 25% of the time in addition to regular commuting between southern California campuses
Able to serve on Boards and maintain leadership roles within the community, including regular attendance at events outside of regular business hours

Managing Director Head of Regulatory Consulting Resume Examples & Samples

Serve as head of the newly created Consulting Americas Regulatory practice
Build and grow the Consulting Americas Regulatory practice from the ground up
Stay abreast of relevant regulatory developments
Serve as advisor to leadership during implementation of Regulatory-related recommendations
Partner closely with internal regulatory subject matter experts
Remain accountable for quality and timeliness of overall project delivery
Lead and manage presentations for senior executive management
Build long-term relationships with senior executive clients
Lead proposals to acquire new projects
15 + years of experience with a Regulator, in a regulatory-related role in a Corporate and investment bank, or leading large transversal projects within a Regulatory Consulting practice
Strong executive presence and comfort building partnerships with senior executives
Deep knowledge of industry-wide regulatory/competitor trends
Deep understanding of banking regulations and operations
Oversees delivery of multiple projects independently
Presents convincingly in senior executive client interactions
Ability to deliver quality results against fast-paced project deliverable deadlines
Proven ability to execute complex projects with large number of dependencies
Builds legitimacy with senior executive clients while preserving independence
Solves client conflicts at senior executive management level
Provides honest and independent advice
MBA, JD, or equivalent preferred

Director of Clinical & Regulatory Affairs Resume Examples & Samples

Develop, prepare, execute and manage high quality regulatory and clinical strategy, filings and communications for medical devices and potentially pharmaceuticals as required for approvals, commercialization, and compliance
Provide guidance, develop and oversee strategy to support approved and planned products
Identify additional commercial opportunities
Develop, manage and interact with domestic and international regulatory authority personnel, consultants and vendors at appropriate stages of development to ensure success of programs
Regulatory representative, including mentoring and directing internal and external regulatory resources and representing the company’s regulatory function at regulatory body meetings
Represent regulatory strategy to current and potential external partners in business initiatives
Develop adequate resources to ensure support of goals and objectives, including implementation and maintenance of systems and procedures to maximize efficiency and compliance
Work closely with product development, quality and other teams ensuring regulatory compliance
Facilitate environment of cooperation and teamwork to optimize regulatory outcomes
BS degree in Biology, Biomedical Engineering or relevant field, Masters preferred
10 + years Regulatory Affairs, Clinical Study management expertise with significant exposure to medical or technology devices in a regulated industry
Proven track record of success leading products through regulatory approval
Strong budgeting, problem solving, organizational, planning, analytical and skills
Excellent written, verbal, interpersonal communication, leadership skills with attention to detail
Goal-oriented, self-motivated, self-directed, requiring little direction
Highly committed, flexible, self-confident, and comfortable with uncertainty
Fast learner with ability to operate effectively in new environments
Commitment to collaborate as a strong team member in a fast-paced environment
Ability to gather, integrate, simplify, and explain information from multiple sources
Ability to rely on facts and data to assertively influence individuals throughout the company
Proactively engage and retain vendors or partners in various countries and cultures
Understanding of design controls, quality system, safety regulations, and risk management

Executive Director, R&D Regulatory Safety IT Resume Examples & Samples

Serve as lead business relationship manager for GRACS; accountable to the SVP of GRACS and the leader of MRL IT. Serve as member of GRACS LT
Shapes and influences business strategy
Partners with GRACS to ensure business and IT roadmaps are developed that meet GRACS needs
Partners with business leads and IT leads to establish investment portfolio
Ensures value realization for the investments
Work with GRACS to understand and predict the requirement for new systems, ensuring Horizon 3 is accounted for
All activities must be conducted compliance with company policies and standards, and in compliance with regional and country specific regulations
Responsible to ensure realization on approximately $30-50M annual IT portfolio
At least 8 years of significant technical experience with large scale validated scientific computer systems
At least 5 years of overall IT experience
Drive for results - Strong planning and organization skills
Delivers customer value - committed to understanding and meeting customer needs
Collaborates effectively with and through others to achieve shared goals
Communicates candidly and fluently in English - strong verbal, written and presentation skills
Ethics and integrity

Director Quality Assurance & Regulatory Affairs Resume Examples & Samples

Local Management Representative – Understand and perform tasks described within the Quality System for Management Representative duties
Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions
Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities
Define quality control standards and test; specify test equipment and procedures
Establish and maintain test instrument calibration procedures and maintenance schedules
Establish quality assurance and quality control inspection and testing procedures
Identify quality assurance metrics; analyze and report trends to management
Review and host meeting(s) for timely resolution of nonconforming materials
Active participant in all stages of design development, V&V testing and design control activities, ensuring quality assurance considerations and requirements are met
Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation where necessary
Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications
Assist in preparation for and conducting of regulatory agency inspections
Review the Design History File of the iTero system for completeness and adequacy in conjunction with design review activities
Supervise RA activities to ensure that documentation in support of premarket submissions to obtain clearance/approval for the iTero products globally is accurate and timely
Demonstrated success in a start-up, entrepreneurial work environment
Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents
Understanding of software, electrical and mechanical engineering principles
Ability to work in a team minded approach to achieve individual and company success
Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project programs
Demonstrated project management skills and experience
Proficient in timely review of technical and clinical data
Bachelor’s Degree in a technical discipline with a minimum of 10 years’ experience in the medical device industry
Thorough knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. Additionally, be familiar with the revised ISO 13485 and new EU Medical Device Regulation
Familiar with EN 60601, Safety requirements for medical electrical systems
Familiar with ISO 62304, Medical Device Software – Software Life Cycle processes
Familiar with the regulatory submission requirements for Class I & II medical devices

Director Head of GMO Regulatory & Accounting Controls Resume Examples & Samples

Escalating and Reviewing
Pushing Follow-Up and Appropriate Action Plans
Being a Hands-on Supervisor
Setting the Right Tone
Establishing Appropriate Procedures
Embracing Good Compliance
Head of GMO Regulatory & Accounting Controls
Charged with delivering an efficient, robust and best-in-practice control environment for Global Markets Operations
Responsible to deliver fully controlled and substantiated sub-ledger environments for broker dealer and some local branch entities
Ensure adherence to all Regulatory reporting requirements under ownership
Deployment of Data Governance principles and requirements across the department
Develop collaborative relationships with the Business, IT, Compliance, Audit, and Finance to partner on all initiatives that require Regulatory and Accounting Control Operational oversight
Efficient management of internal and external Audit and Regulatory examinations
Chair of forums that transparently communicate status of Regulatory and Accounting control indicators and reporting
Management of / key stakeholder in large scale project initiatives
Change Management – mandated to continually evaluate, enhance, and upgrade control tools and reporting in alignment with bank and external requirements
Issue Management - Adept at ensuring the department delivers timely resolution of issues and transparently
Resource Management – recruitment, career and skill development, compensation, promotion, performance, mentoring, and training
15 years+ in financial services industry with control expertize
Executive gravitas, excellently presented, articulate, adept at managing production and chairing executive level forums
Autonomous with excellent leadership and motivation skills
Subject matter expert of Global Markets products and familiarity with Operational systems
In depth knowledge of functional connections between Controls, Regulatory, MO, BO, Finance, FO
Knowledge of regulations such as TRACE, OATS, FED Reporting , ACT, LOPR, INSITE, Large Trader and Bluesheets
Extensive Regulatory and Accounting experience
Proven success at large scale project management
Proven success managing system deployments, BRDs, UATs, and new product & business integrations
Solution provider with ability to execute to full completion
Demonstrated history of managing competing demands

Regional Regulatory Quality & Compliance Associate Director Resume Examples & Samples

Assist in the preparation and facilitation of Health Authority and Notifying Body inspections and audits
Facilitate non-compliance investigations to initiate root-cause analysis in an effort to problem solve and drive process improvement
For inspections, audits and investigations closely follow corrective and preventative actions (CAPA) to ensure their completion in a timely manner
Collaborate with the Regional Quality & Compliance Lead, Regulatory Affairs Regional & Country Leads, Business Process Management and Process Owners to assist in the creation of quality management plans which outline metrics for key business processes
Assist in risk assessment activities and risk mitigation plan development
Collaborate on process improvement initiatives with Business Process Management and other process owner and stakeholders
Collaborates with the Regulatory Quality & Compliance Lead and functional areas in monitoring key metrics within the region/country for trend analysis and development of corrective and preventative action plans. Communicating metric data and analysis for oversight by senior management on a quarterly basis
Accountable to ensure that corrective and preventative action plans to inspection, audit and non-compliance reports have been executed and CAPA evidence is collected
Supports the Regional Regulatory Quality & Compliance Lead with trending of current audits, inspection and investigation observations
Minimum of 5-7 years of working experience within a Regulatory compliance or Pharmacovigilance, or Quality function
Ability to influence others across levels of the organization
Demonstrates a track record of accomplishments
Extensive experience in GCPs, GMPs or GLPs
Process Improvement Management, Root cause analysis/problem solution, excellent communication with relevant area
Possesses mastery of written and spoken English, beneficial to have mastery of another language(s)

Director of Quality & Safety Regulatory Resume Examples & Samples

The daily management of the hospital quality and patient safety team, including risk, infection control, patient advocacy and performance improvement
Works closely with SEMC leadership and leadership at the Corporate level to assure alignment of standard work, implementation of best practices and a culture of safety in a learning organization
Coordinates the regulatory compliance program to meet the standards identified by the JCAHO, DPH and CMS, including the National Patient Safety Goals. Support project structure to insure all staff is involved in regulatory readiness on a daily basis, including tracer rounds with defined tools and processes that include feedback from the patient and/or family, rounds with
Excellent communication skills accompanied by the ability to analyze and present data to influence behavior, stimulate innovation, promote best practices and drive organizational change
Highly skilled change agent with demonstrable sensitivity to the interpersonal, group dynamic, organization, political and perceptual issues associated with change
Results orientation accompanied by the skill set required to conceptualize, implement and operationalize a user-friendly clinical excellence and patient safety program
Demonstrated ability to create and sustain momentum through relationship building and collaborative management

Facilities Operations Regulatory Director Resume Examples & Samples

Serves on Banner regulatory compliance, emergency management, and safety committees to represent Facilities Operations and integrate programs and direction across the organization
Obtains or creates interpretations/clarification for regulatory, emergency management, and safety requirements, plans the dissemination of the information, organizes and/or conducts training, and implements programs to ensure full compliance
Provides leadership and supervision of implementation of programs and ongoing compliance of new and existing programs. Intercedes where necessary to ensure complete and consistent compliance across Banner Health through direct intervention and partnering with the other Facilities Operations leadership
Serves as part of the Facilities Operations leadership team to ensure integration of regulatory, emergency management, and safety issues into all services, planning, and programs
Monitors ongoing state and national regulation, code, and rule making processes. Participates on state and national committees and teams to influence the processes in an appropriate direction for healthcare that includes effectiveness, practicality, and cost-benefit
Along with other members of the team, promotes financial stewardship and operational excellence for all assigned areas of responsibility, in both operational and capital acquisition processes. Allocate financial, information, and human capital for improvement activities, ensuring the efficient delivery of cost effective services. Establishes performance measures, assesses and evaluates operations, and works with department management to assure efficient and effective delivery of services

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