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Become A Regulatory Affairs Manager

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Working As A Regulatory Affairs Manager

  • 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

  • $102,736

    Average Salary

What Does A Regulatory Affairs Manager Do At Kelly Services

* Develops and communicates regulatory support with the goal of achieving timelines and milestones.
* Coordinates meetings, solicits agenda topics from team members for regulatory team meetings as well as produces meeting summaries/minutes.
* Collaborates with pertinent team members to ensure that deliverables are available in a timely manner.
* Assists in managing time sensitive submission projects.
* Experience with regulatory submissions and approval processes is highly preferred.
* Understanding of IND, NDA, and eCTD dossier component requirements is preferred

What Does A Regulatory Affairs Manager Do At Post Holdings

* Manage projects within a given time frame.
* Provide technical information and perspective on nutrition facts panels, claims, nutrition validation laboratory analysis, new products, and ingredients.
* Provide current and accurate product-related
* information to internal and external customers which addresses and meets their needs
* Post Holdings is an equal opportunity employer and gives consideration for employment to qualified applicants without regard to race, color, religion, national origin, ancestry, age, sex, gender, gender identity, gender expression, sexual orientation, genetic
* information, veteran status, medical condition, marital status, or a physical or mental disability.
* Post Holdings provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a
* covered veteran and any other category protected under applicable federal, state, provincial and local laws.
* Please view Equal Employment Opportunity Posters provided by OFCCP
* here

What Does A Regulatory Affairs Manager Do At Novartis Pharmaceuticals

* Responsible for preparation/supervision of preparation of regulatory submissions, including INDs, NDA, supplements, amendments, and variations.
* Responsibilities will include interaction with FDA and other regulatory agencies throughout the development of projects, including support for regulatory agency meetings, teleconferences, Advisory Committee meetings, etc.
* Production of associated records of regulatory meetings will be required along with the preparation of briefing documents.
* This individual will also be responsible for researching and the review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings, to support the development of optimal regulatory strategies to support the successful submissions and achievement of target product labeling.
* Identify and evaluate complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
* Experience with 505(b)(2) submission required.
* Experience with bio-similar submissions is highly desirable

What Does A Regulatory Affairs Manager Do At Regeneron Pharmaceuticals

* Manages the development, review, approval, and maintenance of labeling for designated products.
* Leads the Cross Functional Labeling Team and manages labeling projects for CCDS, USPI, EU SmPC, and local labeling effectively, and independently. (80%)
* Participates in the product development team for early development product to provide labeling leadership in developing target labeling concept to guide the design and analysis plan for clinical trials. (5%)
* Mentors the junior staff members in labeling project and process management to build labeling expertise. (5%)
* Prepares the submission ready labeling documents including the SPL and packaging artworks.
* Maintains and tracks labeling documents in the labeling repository and electronic system as appropriate. (5%)
* Monitor the worldwide regulation changes pertaining to Labeling regulations and maintain the labeling SOP and work instructions. (5

What Does A Regulatory Affairs Manager Do At Amgen

* Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards
* Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4)
* Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
* Write other regulatory submission documents (eg, RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications)
* Manage study timelines for regulatory documents and regulatory submission strategy
* Act as a functional area representative and lead on product teams
* Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
* Ensure quality of regulatory submission documents at all stages of development
* Provide expertise and guidance on document design and principles of good medical writing to the department and product teams
* Participate in departmental meetings, as well as departmental and cross-departmental initiatives, as appropriate

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Regulatory Affairs Manager Demographics

Gender

Female

53.1%

Male

43.9%

Unknown

2.9%
Ethnicity

White

59.1%

Hispanic or Latino

14.1%

Asian

11.6%

Black or African American

10.8%

Unknown

4.4%
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Languages Spoken

Spanish

30.3%

French

18.0%

German

10.1%

Portuguese

6.7%

Chinese

5.6%

Mandarin

4.5%

Italian

4.5%

Russian

3.4%

Czech

2.2%

Hindi

2.2%

Arabic

2.2%

Turkish

1.1%

Haida

1.1%

Dutch

1.1%

Vietnamese

1.1%

Japanese

1.1%

Carrier

1.1%

Slovak

1.1%

Croatian

1.1%

Gujarati

1.1%
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Regulatory Affairs Manager Education

Schools

University of Phoenix

13.6%

Northeastern University

9.1%

Johns Hopkins University

8.6%

Michigan State University

7.6%

George Washington University

5.1%

Harvard University

5.1%

Temple University

4.5%

Georgetown University

4.5%

Pennsylvania State University

4.5%

University of Florida

4.5%

Arizona State University

4.0%

University of Wisconsin Extension

3.5%

University of Southern California

3.5%

San Diego State University

3.5%

University of Washington

3.0%

University of Texas at Austin

3.0%

George Mason University

3.0%

Case Western Reserve University

3.0%

Purdue University

3.0%

Drexel University

3.0%
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Majors

Business

21.4%

Pharmacy

12.2%

Biology

10.3%

Law

9.2%

Chemistry

7.4%

Management

5.7%

Finance

4.2%

Political Science

3.9%

Health Care Administration

3.1%

Public Health

2.8%

Environmental Control Technologies/Technicians

2.5%

Biochemistry, Biophysics, Molecular Biology

2.2%

Psychology

2.2%

Education

2.1%

Communication

2.1%

Electrical Engineering

1.9%

Nursing

1.8%

Environmental Science

1.8%

Biomedical Engineering

1.7%

Legal Research And Advanced Professional Studies

1.5%
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Degrees

Masters

36.9%

Bachelors

33.0%

Doctorate

12.0%

Other

10.9%

Certificate

4.5%

Associate

1.9%

Diploma

0.8%

License

0.1%
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Job type you want
Full Time
Part Time
Internship
Temporary

Real Regulatory Affairs Manager Salaries

Job Title Company Location Start Date Salary
Senior Governance and Regulatory Affairs Manager The Royal Bank of Scotland PLC Stamford, CT Sep 01, 2015 $200,000
Regulatory Affairs Manager Stripe, Inc. San Francisco, CA Feb 16, 2016 $175,000
Senior Regulatory Affairs Manager St. Jude Medical Cardiology Division Saint Paul, MN Aug 20, 2016 $169,500
Global Regulatory Affairs, Latin America Manager Bayer Healthcare Pharmaceuticals NJ Nov 25, 2016 $160,078
Regional Regulatory Affairs Manager-Latin America Bayer Healthcare Pharmaceuticals, Inc. NJ Mar 09, 2016 $157,016
Manager, Regulatory Affairs Cutanea Life Sciences Inc. Wayne, PA Oct 01, 2015 $150,000
Regulatory Affairs Manager API Inc. Fairfield, NJ Jun 24, 2015 $149,594
Manager, Regulatory Affairs Non-Sterile TEVA Pharmaceuticals USA, Inc. Horsham, PA Nov 01, 2016 $145,500 -
$150,500
Regulatory Affairs Manager Citron Pharma LLC East Brunswick, NJ Jun 15, 2015 $144,310
Manager, Regulatory Affairs TEVA Pharmaceuticals USA Inc. Horsham, PA Dec 14, 2015 $138,944 -
$145,000
Manager, Regulatory Affairs TEVA Pharmaceuticals USA Horsham, PA May 04, 2015 $138,944 -
$144,000
Manager, CMC Regulatory Submissions Shire Human Genetic Therapies Inc. Lexington, MA May 15, 2016 $138,000
Manager, Global Regulatory Affairs CMC Reckitt Benckiser Pharmaceuticals, Inc. Richmond, VA Jun 26, 2015 $135,824
Regulatory Affairs Manager Allergan Sales, LLC (Subsidiary of Allergan, Inc.) Irvine, CA Aug 28, 2015 $135,000
Manager, Regulatory Affairs, CMC Abbvie Inc. North Chicago, IL Jul 22, 2015 $115,119
Manager, Scientific Affairs (Claims) ELC Management LLC Melville, NY Aug 24, 2015 $115,000
Manager, Regulatory Affairs Goodman Manufacturing Company, L.P. Herndon, VA Apr 28, 2016 $115,000
Manager, Regulatory Affairs Vertex Pharmaceuticals, Inc. Boston, MA Feb 15, 2016 $115,000 -
$135,000
Senior Publisher, Regulatory Affairs Abbvie Inc. North Chicago, IL Aug 10, 2015 $113,750
Regulatory Affairs Manager Generics Bidco II Charlotte, NC Feb 15, 2015 $112,000
Regulatory Affairs Senior Manager Amgen Inc. Thousand Oaks, CA Feb 10, 2016 $110,388
Regulatory Labeling Manager Amgen Inc. Thousand Oaks, CA Nov 05, 2015 $110,321
Regulatory Affairs, Senior Manager Amneal Pharmaceuticals, LLC Piscataway, NJ Sep 25, 2016 $96,262
Regulatory Affairs Manager Amgen Inc. Thousand Oaks, CA Oct 21, 2015 $95,000
Regulatory Affairs Manager Medivators, Inc. Plymouth, MN Apr 14, 2016 $95,000
Regulatory Affairs Manager Neurologica Corporation A Subsidary of Samsung Danvers, MA Jan 26, 2015 $95,000
Senior Policy Advisor, Regulatory Affairs Institute of International Finance Washington, DC Aug 18, 2015 $94,848 -
$130,000
Policy Advisor, Regulatory Affairs Institute of International Finance, Inc. Washington, DC Aug 01, 2015 $94,848 -
$230,738
Regulatory Labeling Manager Amgen Inc. Thousand Oaks, CA Oct 15, 2015 $94,438
Regulatory Labeling Manager Amgen Inc. Thousand Oaks, CA Oct 23, 2015 $94,438

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Top Skills for A Regulatory Affairs Manager

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  1. Regulatory Documents
  2. FDA
  3. Procedures
You can check out examples of real life uses of top skills on resumes here:
  • Prepare and collate materials stored in the regulatory binder including all pertinent regulatory documents, correspondence and approved documents.
  • Reviewed FDA reporting of promotional materials and submissions.
  • Developed infrastructure for divisional scientific publication procedures, created publication policies in alignment with regulatory, compliance and ethics standards.
  • Develop and implement regulatory requirements, policies, and any supporting position paper and rationale documentation as needed by client groups.
  • Establish processes to review safety statistics/metrics with operations and senior management.

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Top Regulatory Affairs Manager Employers

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Jobs From Top Regulatory Affairs Manager Employers

Regulatory Affairs Manager Videos

Designing Your Career as a Regulatory Professional

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Senior Quality Engineer | Regulatory Affairs Manager [bkjrecruiter]

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