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Become A Regulatory Affairs Director

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Working As A Regulatory Affairs Director

  • Evaluating Information to Determine Compliance with Standards
  • Getting Information
  • Communicating with Supervisors, Peers, or Subordinates
  • Communicating with Persons Outside Organization
  • Updating and Using Relevant Knowledge
  • Mostly Sitting

  • $150,545

    Average Salary

What Does A Regulatory Affairs Director Do At Astrazeneca Pharmaceuticals LP

* Accountable for the development and implementation, at a regional or global level, of the regulatory strategy for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business and patients.
* Leads and develops a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirements.
* Leads the planning and construction of the global dossier and core prescribing information (GRL).
* Conducts regulatory risk planning and mitigation.
* Lead the development and implementation of innovative strategies to maximize the likelihood of regulatory success.
* Serves as the single point of contact and Global Regulatory Affairs (GRA) representative on Regional and/or Product Development Teams (PDT)/Global Product Teams (GPT).
* Leads (GRL) the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement.
* Through the GRST, ensures that regional regulatory needs are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Development Plan.
* Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures.
* The Global Regulatory Leader (GRL) is also accountable for product maintenance, supply and compliance activities associated with marketed brands.
* Lead (GRL)/be part (Regional RAD) of the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
* Partner with marketing company staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.
* Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
* Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.(GRL accountability in close collaboration with Regional RAD).
* Leads the development, communication and updates the Regulatory Strategy Document for assigned products/projects.
* Ensure appropriate consultation and peer review. (GRL)
* Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise regional and/or Global Product Teams (GPT) accordingly.
* Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
* Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
* Regional RAD is accountable for interacting with the regional commercial and cross-functional teams to ensure business needs are understood within the GRST and to ensure regional commercial engagement with the proposed regulatory strategies/risks/mitigation plans.
* Education and Experience
* Bachelor's degree in a science related field and/or other appropriate knowledge/experience
* Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g.
* FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre
* NDA/BLA, EOP2 meetings etc.).
* >5 years experience or equivalent of regulatory drug development including product approval/launch.
* Expert knowledge of regulatory affairs within one or more therapeutic areas.
* Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g.
* Global, European, International, Marketing Company or experience at a health authority.
* Proven leadership and program management experience.
* Ability to think strategically and critically evaluate risks to regulatory activities.
* Ability to work strategically within a complex, business critical and high profile development program.
* Successful contribution to a major regulatory approval at a global or regional level.
* A scientific and clinical understanding of the regulatory sciences.
* Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
* Reporting Relationship Direct Reports
* None Associated topics: community, external, marketing agency, movement, public relations, relations, senior, senior manager, sr

What Does A Regulatory Affairs Director Do At Amgen

* Lead one or more GRTs within Amgen's GRA department.
* Develop and execute regulatory strategies for in vitro diagnostics and companion diagnostics
* Develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions.
* Provide regulatory expertise and guidance to product teams (eg, PST.)
* Develop and execution of the global regulatory product strategy.
* Lead global regulatory team(s).
* Represent GRA on the PST and other key commercialization governance bodies.
* Develop Global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan.
* Represent GRA on PST to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling.
* Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
* Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance.
* Lead the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes).
* Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents).
* Monitor and assess impact of relevant global regulations, guidance's, and current regulatory environment.
* Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy.
* Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood.
* Produce strategies that provide innovative alternatives which communicate the associated risks.
* Communicate Amgen's position consistently cross-functionally and across all documents.
* Develop the ability to articulate and educate the likelihood of regulatory success based on proposed strategies.
* Develop ability to accurately predict expectations and outcomes by regulatory agencies.
* Direct global regulatory agency interaction strategies, in collaboration with regional colleagues.
* Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g.
* GRTs, filing teams).
* Attend key regulatory agency meetings which could impact the global product strategy.
* Lead GRT to develop and execute team goals.
* Integrate regional regulatory representative input into GRT and regulatory plans.
* Represent GRA on key commercialization teams (e.g, PST, GDT, GST).
* Represent Amgen GRA on external partnership teams at the PST level.
* Provide education and training on regulatory strategies and compliance issues to other functions.
* Ensure regulatory compliance for product

What Does A Regulatory Affairs Director Do At Abbvie

* Candidate will be responsible for contributing to and implementing regulatory strategies to support assigned projects within Therapeutic Area of responsibility for Latin America
* Review, compile, and submit variations, new applications, supplements and amendments and periodic reports, as well as responses to Health Authorities as needed
* Development, defense, and implementation of robust Regulatory Strategy and Tactical plan for assigned projects
* Responsible for managing complex issues and providing leadership to assigned teams
* Responsible to ensure regulatory commitments are met for assigned projects
* Independently manages projects, product assignments and is responsible for managing timelines with minimal supervision
* Provides recommendations and guidance on project decisions and makes recommendations for improvements
* Steers projects and communicates to manager any issues that would result in a delay
* Effectively negotiate regulatory agreements with affiliates, commercial organization and other stakeholders

What Does A Regulatory Affairs Director Do At Intersect ENT Inc.

* Regulatory representation and leadership to cross-functional product development teams, development of regulatory strategies and support for Intersect ENTs clinical and non-clinical development programs, marketing applications and post-marketing activities.
* Plan, direct and prepare regulatory submissions (IDE, 510(k), PMA, PMAS) to ensure compliance with FDA and international regulations and guidelines.
* Responsible for regulatory timelines and management of IDE/PMA, and global regulatory submissions.
* Support IDE application including responsibility for safety reporting requirements, supplements and annual reports.
* Perform research regarding regulatory strategic recommendations, and new and revised regulations and guidances and provide global regulatory guidance, especially as it pertains to current thinking related to combination drug/device products.
* Responsible for developing and maintaining department SOPs.
* Accountable for successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects.
* Participate with all disciplines within the organization to obtain and/or provide information for regulatory filings.
* Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements (e.g.
* US, EU, Japan, China, etc.).
* Maintain well-organized, auditable regulatory files.
* Provide regulatory support for quality assurance and regulatory compliance activities.
* Represent RA functional area in the review and approval of Engineering Change Orders (ECO), providing regulatory assessments regarding development and commercial manufacturing processes and changes and other anticipated changes.
* Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials.
* Provide coaching to direct reports

What Does A Regulatory Affairs Director Do At Polaris Industries

* Serve as the primary point of contact, with national safety regulators in North America generally and specifically with respect to safety reporting and recall matters.
* Engage with national safety regulators outside of North America and national and local regulators on non-safety matters worldwide, as needed, in conjunction with the Product Compliance function, other components of the Legal Department and Polaris’ Subsidiaries.
* Manage preparation and submission in North America of, and assist Subsidiaries worldwide in connection with, recall-related filings.
* Serve as a primary participant in the company’s Product Action Procedure and other internal review processes related to the discharge of the company’s regulatory obligations.
* Prepare or coordinate the company’s comments and other engagement on regulatory rulemaking topics of importance.
* Represent the company on technical committees and other bodies of industry associations worldwide, in conjunction with subject matter experts in Engineering and Product Compliance.
* Lead or support cross-functional corporate and industry initiatives designed to create or maintain a reasonable regulatory environment.
* Manage communication and reporting to internal stakeholders, including but not limited to the Executive Team, Business Units, Sales, Marketing and Communications, Product Compliance and Subsidiaries, of forthcoming and in progress recalls and other significant regulatory actions.
* Manage other members of the Polaris Regulatory Affairs team, as assigned

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Regulatory Affairs Director Demographics

Gender

Male

54.0%

Female

44.4%

Unknown

1.5%
Ethnicity

White

63.4%

Hispanic or Latino

13.2%

Black or African American

12.4%

Asian

7.4%

Unknown

3.5%
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Languages Spoken

Spanish

27.3%

German

18.2%

Portuguese

9.1%

Marathi

9.1%

French

9.1%

Carrier

9.1%

Hindi

9.1%

Italian

9.1%
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Regulatory Affairs Director Education

Schools

George Washington University

10.6%

Northeastern University

7.6%

University of Phoenix

7.6%

Michigan State University

7.6%

Drexel University

6.1%

Pennsylvania State University

6.1%

University of Maryland - University College

4.5%

University of Pennsylvania

4.5%

University of Kentucky

4.5%

New York University

4.5%

Harvard University

4.5%

Central Michigan University

4.5%

John Marshall Law School

4.5%

Carnegie Mellon University

4.5%

Washington University in Saint Louis

3.0%

North Carolina State University

3.0%

University of Rochester

3.0%

Southern Illinois University Carbondale

3.0%

Temple University

3.0%

Boston University

3.0%
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Majors

Business

22.3%

Law

14.6%

Biology

9.2%

Pharmacy

6.3%

Management

5.3%

Psychology

4.4%

Biochemistry, Biophysics, Molecular Biology

3.9%

Public Administration

3.9%

Nursing

2.9%

Chemistry

2.9%

Finance

2.9%

Human Resources Management

2.9%

Pharmacology

2.9%

Accounting

2.9%

Legal Research And Advanced Professional Studies

2.4%

History

2.4%

Electrical Engineering

1.9%

Education

1.9%

Economics

1.9%

Political Science

1.9%
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Degrees

Masters

37.7%

Bachelors

27.5%

Doctorate

19.3%

Other

10.2%

Certificate

3.6%

Associate

1.3%

License

0.3%
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Real Regulatory Affairs Director Salaries

Job Title Company Location Start Date Salary
Regulatory Affairs Director Merck Sharp & Dohme Corp North Wales, PA Mar 11, 2016 $220,667
Director, Corporate Regulatory Affairs, Systems & Standards Hologic, Inc. Marlborough, MA Aug 02, 2016 $190,000
Director, Regulatory Affairs North America Strides Pharma Inc. Lambertville, NJ Jul 10, 2015 $186,035
Director, Regulatory Affairs Lupin Pharmaceuticals, Inc. Baltimore, MD May 01, 2015 $185,000
Director, Regulatory Affairs Lupin Pharmarceuticals, Inc. Baltimore, MD Mar 06, 2016 $185,000
Director, Regulatory Affairs Lupin Pharmarceuticals, Inc. Baltimore, MD Jan 09, 2016 $185,000
Director Regulatory Affairs Roche Molecular Systems, Inc. Pleasanton, CA Jan 15, 2010 $168,000
Director, Drug Regulatory Affairs Hoffmann-La Roche Inc. Nutley, NJ Aug 19, 2011 $164,439
Director, Regulatory Affairs Icon Clinical Research, Inc. MD Nov 14, 2014 $160,000 -
$180,000
Director, Regulatory Affairs Amneal Pharmaceuticals LLC Piscataway, NJ Aug 29, 2016 $158,061
Director of Regulatory Affairs Invagen Pharmaceuticals, Inc. Hauppauge, NY Jun 15, 2014 $142,200
Director, Global Regulatory Affairs Stiefel Laboratories, Inc. Parkton, NC Sep 27, 2012 $136,300 -
$183,250
Director of Regulatory and Scientific Affairs Kerry Inc. South Beloit, IL Sep 06, 2013 $130,000
DIR. Technical & Regulatory Affairs: Environmental Cruise Lines International Association, Inc. Arlington, VA Oct 01, 2012 $130,000
Director of Legal Affairs and Operations Storm King Art Center Inc. NY Feb 07, 2014 $113,859
Director of Regulatory Affairs Invagen Pharmaceuticals, Inc. Hauppauge, NY Jun 15, 2011 $100,000
Director, Regulatory Affairs Apicore, LLC Somerset, NJ Jan 31, 2014 $95,400
Regulatory Affairs Director DFW Instrument, LLC Addison, TX Jan 05, 2016 $82,222 -
$104,416

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Top Skills for A Regulatory Affairs Director

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  1. Regulatory Documents
  2. Compliance
  3. FDA
You can check out examples of real life uses of top skills on resumes here:
  • Initiated, developed and implemented plant facility safety training material which improved company safety compliance by 84%.
  • Maintained regular contact and consulted as required with counsel knowledgeable in FDA regulatory matters.
  • Directed research and new product development from concept through initial commercial production for contract manufacturing organization.
  • Reviewed/approved labeling to ensure substantiation of claims, adequate information, and inclusion of cautions/warnings in conformance with regulatory requirements.
  • Coordinated legal and contractual procedures with foreign office Managing Directors.

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Top Regulatory Affairs Director Employers

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