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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

  • $97,000

    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 Career Paths

Regulatory Affairs Manager
Manager Operations Manager
Senior Operations Manager
9 Yearsyrs
Manager General Manager
Vice President & General Manager
12 Yearsyrs
Manager Product Manager
Senior Product Manager
9 Yearsyrs
Regulatory Affairs Director
12 Yearsyrs
Senior Manager Vice President
Senior Vice President-Operations
14 Yearsyrs
Senior Manager Senior Project Manager
Director Program Management
12 Yearsyrs
Senior Manager Finance Director
Senior Director Of Finance
14 Yearsyrs
Quality Assurance Director
Director Of Quality
14 Yearsyrs
Quality Assurance Director Director
Global Director
14 Yearsyrs
Quality Assurance Director Operations Director
Vice President Of Manufacturing
14 Yearsyrs
Regulatory Affairs Director Vice President
Corporate Vice President
12 Yearsyrs
Director Medical Director
Chief Medical Officer
8 Yearsyrs
Director Development Director
Director Of Advancement
11 Yearsyrs
Quality Assurance Director
11 Yearsyrs
Vice President
Compliance Vice President
12 Yearsyrs
Regulatory Affairs Director Senior Director
Vice President Of Research And Development
13 Yearsyrs
Quality Manager Operations Manager
Service Operations Manager
8 Yearsyrs
Quality Manager Program Manager
Operations Program Manager
9 Yearsyrs
Quality Manager
Quality Systems Manager
12 Yearsyrs
Compliance Manager
Compliance Director
12 Yearsyrs
Compliance Manager Assistant Vice President
Division Vice President
11 Yearsyrs
Compliance Manager Operations Director
Executive Director Of Operations
7 Yearsyrs
Associate Director Program Director
Interim Executive Director
11 Yearsyrs
Associate Director Marketing Director
Director, Strategic Marketing
10 Yearsyrs
Associate Director Operations Director
Director Of Operations And Development
9 Yearsyrs
President Chief Operating Officer
Director Of Clinical Operations
12 Yearsyrs
Senior Director Operations Vice President
Director Of Construction
13 Yearsyrs
Compliance Manager
9 Yearsyrs
Product Manager Operations Manager
Logistics Operations Manager
7 Yearsyrs
Product Manager
Global Product Manager
9 Yearsyrs
Director Of Quality Operations Vice President
Director, Special Projects
9 Yearsyrs
Director Of Quality Clinical Director
Director Of Quality Management
13 Yearsyrs
Director Of Quality
Director Of Technology And Services
11 Yearsyrs
Office Manager Project Manager
Manager, Project Management
9 Yearsyrs
Office Manager
Office And Operations Manager
6 Yearsyrs
Office Manager Controller
Director Of Operations And Finance
11 Yearsyrs
Assistant Director Communications Director
Director Of Public Affairs
7 Yearsyrs
Assistant Director Finance Director
Contracts Director
12 Yearsyrs
Assistant Director Managing Director
Director, Global Business Development
14 Yearsyrs
Principal Superintendent
Quality Control Manager
7 Yearsyrs
Principal Information Technology Director
Director Of Information
7 Yearsyrs
Communications Director Community Development Director
Planning Director
10 Yearsyrs
Communications Director Director Of Marketing & Development
Director Of Marketing Services
9 Yearsyrs
Senior Quality Assurance Manager
Senior Quality Manager
12 Yearsyrs
Business Development Manager Senior Product Manager
Principal Product Manager
10 Yearsyrs
Business Development Manager Partner
Senior Partner
9 Yearsyrs
Business Development Manager Consultant/Project Manager
Global Project Manager
9 Yearsyrs
Regulatory Compliance Director
12 Yearsyrs
Director Of Quality Management Administrative Director
Systems Director
11 Yearsyrs
Owner Business Owner
Quality Assurance Manager
9 Yearsyrs
President Maintenance Director
Quality Control Director
9 Yearsyrs
Program Manager Senior Operations Manager
Director Of Distribution
11 Yearsyrs
Program Manager Supply Chain Manager
Process Improvement Manager
10 Yearsyrs
Development Director Deputy Director
Director, Strategic Initiatives
11 Yearsyrs
Development Director Director, Learning And Development
Organizational Development Director
11 Yearsyrs
Senior Quality Assurance Manager Senior Manager-Systems
Senior Service Manager
10 Yearsyrs
Senior Project Manager Director Of Project Management
Clinical Research Director
11 Yearsyrs
Regional Manager Human Resources Manager
Director, Human Resources And Administration
9 Yearsyrs
Regional Manager Development Manager
Senior Development Manager
10 Yearsyrs
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Do you work as a Regulatory Affairs Manager?

Help others decide if this is a good career for them

Do you work as a Regulatory Affairs Manager?

Average Yearly Salary
$97,000
View Detailed Salary Report
$56,000
Min 10%
$97,000
Median 50%
$97,000
Median 50%
$97,000
Median 50%
$97,000
Median 50%
$97,000
Median 50%
$97,000
Median 50%
$97,000
Median 50%
$170,000
Max 90%
Best Paying Company
SSi Design-Build Constructors
Highest Paying City
Bismarck, ND
Highest Paying State
North Dakota
Avg Experience Level
3.4 years
How much does a Regulatory Affairs Manager make at top companies?
The national average salary for a Regulatory Affairs Manager in the United States is $97,880 per year or $47 per hour. Those in the bottom 10 percent make under $56,000 a year, and the top 10 percent make over $170,000.

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
Senior Publisher, Regulatory Affairs Abbvie Inc. North Chicago, IL May 05, 2016 $117,947
Manager, Regulatory Affairs Development Takeda Development Center Americas, Inc. Deerfield, IL Jul 10, 2016 $116,500 -
$178,200
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 Vertex Pharmaceuticals, Inc. Boston, MA Feb 15, 2016 $115,000 -
$135,000
Manager, Regulatory Affairs Goodman Manufacturing Company, L.P. Herndon, VA Apr 28, 2016 $115,000
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 Engineer Intuitive Surgical Operations, Inc. Sunnyvale, CA Feb 29, 2016 $97,947 -
$117,947
Regulatory Affairs Engineer Intuitive Surgical Operations, Inc. Sunnyvale, CA Jan 12, 2015 $97,926 -
$122,600
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
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

  1. Ensure Compliance
  2. FDA
  3. Regulatory Affairs
You can check out examples of real life uses of top skills on resumes here:
  • Partnered with local counterparts to ensure compliance with all federal and state contractual and regulatory obligations.
  • Reviewed FDA reporting of promotional materials and submissions.
  • Proofread and edited documents related to intellectual property enforcement, regulatory affairs, trademarks, and patents.
  • Prepare and collate materials stored in the regulatory binder including all pertinent regulatory documents, correspondence and approved documents.
  • Established a single regulatory research response unit; resulting in improved productivity and elimination of redundant requests.

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Top 10 Best States for Regulatory Affairs Managers

  1. Massachusetts
  2. District of Columbia
  3. Delaware
  4. Minnesota
  5. California
  6. Virginia
  7. Colorado
  8. North Carolina
  9. Maryland
  10. Connecticut
  • (315 jobs)
  • (62 jobs)
  • (19 jobs)
  • (104 jobs)
  • (664 jobs)
  • (55 jobs)
  • (34 jobs)
  • (92 jobs)
  • (71 jobs)
  • (32 jobs)

Regulatory Affairs Manager Resume Examples And Tips

The average resume reviewer spends between 5 to 7 seconds looking at a single resume, which leaves the average job applier with roughly six seconds to make a killer first impression. Thanks to this, a single typo or error on your resume can disqualify you right out of the gate. At Zippia, we went through over 2,447 Regulatory Affairs Manager resumes and compiled some information about how best to optimize them. Here are some suggestions based on what we found, divided by the individual sections of the resume itself.

Learn How To Create A Top Notch Regulatory Affairs Manager Resume

View Resume Examples

Regulatory Affairs Manager Demographics

Gender

Female

48.0%

Male

40.0%

Unknown

12.0%
Ethnicity

White

58.7%

Hispanic or Latino

14.1%

Asian

11.8%

Black or African American

11.0%

Unknown

4.5%
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Foreign Languages Spoken

Spanish

29.7%

French

16.9%

German

11.0%

Portuguese

6.8%

Chinese

5.1%

Hindi

4.2%

Russian

4.2%

Mandarin

3.4%

Italian

3.4%

Gujarati

2.5%

Arabic

2.5%

Vietnamese

1.7%

Czech

1.7%

Japanese

1.7%

Swedish

0.8%

Marathi

0.8%

Dutch

0.8%

Ukrainian

0.8%

Turkish

0.8%

Haida

0.8%
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Regulatory Affairs Manager Education

Schools

University of Phoenix

16.5%

Northeastern University

13.0%

Johns Hopkins University

6.8%

George Washington University

4.7%

Michigan State University

4.7%

Temple University

4.7%

Georgetown University

4.1%

Pennsylvania State University

4.1%

University of Southern California

4.1%

Ohio State University

3.8%

University of Florida

3.8%

Purdue University

3.8%

Drexel University

3.5%

Fairleigh Dickinson University

3.2%

Rochester Institute of Technology

3.2%

Harvard University

3.2%

American University

3.2%

University of Wisconsin Extension

3.2%

San Diego State University

2.9%

University of Washington

2.9%
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Majors

Business

22.2%

Pharmacy

14.5%

Biology

10.9%

Law

9.0%

Chemistry

6.6%

Management

5.2%

Political Science

4.2%

Finance

3.9%

Health Care Administration

2.8%

Public Health

2.5%

Biochemistry, Biophysics, Molecular Biology

2.3%

Psychology

2.1%

Environmental Control Technologies/Technicians

1.9%

Communication

1.9%

Legal Research And Advanced Professional Studies

1.8%

Nursing

1.8%

Electrical Engineering

1.7%

Biomedical Engineering

1.7%

Microbiology

1.6%

Computer Science

1.6%
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Degrees

Masters

36.7%

Bachelors

34.1%

Doctorate

12.2%

Other

10.3%

Certificate

3.6%

Associate

2.5%

Diploma

0.6%

License

0.0%
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