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Become A Regulatory Affairs Specialist

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Working As A Regulatory Affairs Specialist

  • Evaluating Information to Determine Compliance with Standards
  • Getting Information
  • Updating and Using Relevant Knowledge
  • Interacting With Computers
  • Communicating with Supervisors, Peers, or Subordinates
  • Mostly Sitting

  • $92,000

    Average Salary

What Does A Regulatory Affairs Specialist Do At Kelly Services

* Prepare CMC related supplements to New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologic License Agreements (BLAs).
* Interface with Contract Manufacturing Organizations (CMOs) to obtain the necessary documentation for a CMC related submission.
* Write concise and scientifically accurate sections/updates for Modules 2 and 3.
* Change Controls Management: Provide regulatory assessment on internal and external Change Controls with a focus on CMC related changes.
* Attend Change Control meetings as Regulatory representative
* Annual Reporting: Draft CMC sections within Annual Reports for NDAs, ANDAs and BLAs.
* Interface with CMOs and internal Quality representatives to obtain information required for CMC sections within Annual Reports

What Does A Regulatory Affairs Specialist Do At Nestle

* Demonstrate and deliver on the Regulatory & Scientific Affairs Department (RSA) Strategic Roles:Apply the Regulatory Foundationby developing and maintaining internal networks to effectively accomplish work, e.g., QM, TAG, Marketing, Legalby effectively using Nestl systems, policies and tools,by contributing to the maintenance of Nestl systems, policies and tools, as part of NCE and NQMS, and by identifying opportunities for improvements to them
* Assure Full Regulatory Complianceby applying knowledge of regulations and Nestl policies to review and assure faultless compliance of a) formulas, ingredients and any relevant processing procedures; b) all required and optional label information, including claims; and c) as requested, sensitive communications such as advertising, promotional materials, websites, etc
* Active Engagement in Innovation / Renovationby contributing effectively to I/R process and ingredients with thorough and timely Regulatory Assessments at each stage; and by identifying regulatory hurdles as early as possible, and assisting the Manager or other Specialists in their resolution;by applying a "compliance by design" approach to assure Operations process capabilities are confirmed to deliver on claims and product characteristics
* Contribute to Regulatory Environment Mastershipby providing product, ingredient and label information to assist in assessing impact of regulations or developing Nestl positions as requested
* Other appropriate duties and tasks as assigned by Manager
* Anticipated travel: 0 5%
* Qualifications

What Does A Regulatory Affairs Specialist Do At Integra Lifesciences

* Assists and supports international registrations for distributor partners and regulatory authorities,as required regarding company's licensing and registrations by providing documentation related to international registrations
* Position may also support the review,logging,and tracking of requests as needed.
* Review Engineering Change Requests, Document Change Requests, Labeling, Variances,and other Quality System documentation that requires regulatory review and approval to ensure compliance with national and international government regulations.
* Develop drafts, edits, compiles and obtains internal approval of routine correspondence including technical documentation for CE Marking, Certificate of Foreign Government, and Canadian licensing.
* Assist with data collection and compilation of 510(k) submissions
* Assists in development of procedures to ensure compliance with national and international governmentregulations,current Good Manufacturing Practice (cGMP) and Quality System Regulationsincludingquality system standards such as 21 CFR Part 820 and ISO 13485
* Assists in development of procedures to ensure compliance with national andinternationallabeling requirements as outlinedinISO 13485 and 21 CFR Part 801
* Coordinates with other departments, corporate or marketing partners and international offices to achieve project goals

What Does A Regulatory Affairs Specialist Do At Abbvie

* Prepares regulatory submissions under supervision of RA management
* Analyzes and interprets information that impact regulatory decisions
* Seeks expert advice and technical support as required for strategies and submissions
* For planned regulatory submissions, independently evaluates data, identifies opportunities and risks, weighs alternatives and presents recommendation to product team and management
* Responds to regulatory information requests
* Stays abreast of regulatory procedures and changes in regulatory climate
* Maintains awareness of legislation and current developments within specific area of businessInforms regulatory management of important timely issues
* Follows company policies and procedures for record keeping
* Manages products and change control with an understanding of regulations and company policies and procedures

What Does A Regulatory Affairs Specialist Do At Kelly Scientific Resources

* Coordinate efforts associated with the preparation of regulatory documents or submissions.
* Analyze product complaints and make recommendations regarding their reportability.
* Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
* Coordinate, prepare, or review regulatory submissions for domestic or international projects Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures (possibility).
* Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
* Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Prepare or direct the preparation of additional information or responses as requested by regulatory agencies

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Regulatory Affairs Specialist Career Paths

Regulatory Affairs Specialist
Regulatory Affairs Manager
8 Yearsyrs
Manager Purchasing Manager Contracts Manager
Contracts Director
12 Yearsyrs
Manager Assistant Vice President
Compliance Vice President
12 Yearsyrs
Regulatory Affairs Manager
Regulatory Affairs Director
12 Yearsyrs
Manager Property Manager Compliance Manager
Regulatory Compliance Manager
10 Yearsyrs
Business Analyst Senior Data Analyst- Data Manager
Data Management Manager
10 Yearsyrs
Compliance Specialist Quality Specialist Senior Quality Engineer
Vice-President Of Quality
15 Yearsyrs
Compliance Analyst Senior Analyst Research Manager
Clinical Research Manager
9 Yearsyrs
Compliance Specialist Quality Assurance Manager Regulatory Affairs Manager
Regulatory Compliance Director
12 Yearsyrs
Senior Scientist Research Manager Clinical Research Manager
Clinical Trial Manager
10 Yearsyrs
Senior Consultant Senior Database Administrator Data Manager
Clinical Study Manager
9 Yearsyrs
Senior Analyst Research Manager Clinical Research Manager
Clinical Research Director
11 Yearsyrs
Compliance Analyst Compliance Specialist Regulatory Specialist
Clinical Trials Specialist
7 Yearsyrs
Compliance Auditor Physician Clinical Research Coordinator
Senior Research Coordinator
5 Yearsyrs
Quality Engineer Product Quality Engineer
Product Quality Manager
10 Yearsyrs
Clinical Trial Coordinator Clinical Research Coordinator
Clinical Trials Associate
6 Yearsyrs
Quality Consultant Clinical Consultant Medical Science Liaison
Senior Clinical Research Associate
9 Yearsyrs
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Do you work as a Regulatory Affairs Specialist?

Help others decide if this is a good career for them

Do you work as a Regulatory Affairs Specialist?

Average Yearly Salary
$92,000
View Detailed Salary Report
$52,000
Min 10%
$92,000
Median 50%
$92,000
Median 50%
$92,000
Median 50%
$92,000
Median 50%
$92,000
Median 50%
$92,000
Median 50%
$92,000
Median 50%
$160,000
Max 90%
Best Paying Company
Union Bank
Highest Paying City
Plymouth, MN
Highest Paying State
North Dakota
Avg Experience Level
3.0 years
How much does a Regulatory Affairs Specialist make at top companies?
The national average salary for a Regulatory Affairs Specialist in the United States is $92,134 per year or $44 per hour. Those in the bottom 10 percent make under $52,000 a year, and the top 10 percent make over $160,000.

Real Regulatory Affairs Specialist Salaries

Job Title Company Location Start Date Salary
Regulatory Affairs Specialist, Americas & Asia Emeter Corporation Foster City, CA Sep 27, 2016 $175,000
AD, Regulatory Affairs Biogen, Inc. Cambridge, MA Aug 20, 2016 $159,000 -
$162,000
Regulatory Affairs Specialist Kelly Services, Inc. Raynham, MA Jan 08, 2016 $158,612
AD, Regulatory Affairs Biogen, Inc. Cambridge, MA Sep 08, 2016 $155,000 -
$158,000
Senior Quality and Regulatory Affairs Specialist Medidata Solutions, Inc. New York, NY Sep 14, 2015 $125,000
Staff, Regulatory Affairs Beckman Coulter, Inc. CA Dec 31, 2015 $125,000
Senior Regulatory Affairs Specialist St. Jude Medical Cardiology Division Selma, CA Mar 10, 2016 $120,000
Senior Regulatory Affairs Specialist St. Jude Medical, Inc. Selma, CA Oct 26, 2015 $120,000
Regulatory Affairs Specialist Leading Pharma LLC Fairfield, NJ Apr 10, 2016 $115,000
Regulatory Affairs Specialist Bayer Cropscience Parkton, NC Mar 11, 2015 $110,313
Senior Regulatory Affairs Specialist Abbott Laboratories Milpitas, CA Nov 18, 2016 $109,250
SR. Regulatory Affairs Specialist (Sterile Injectables) Anika Therapeutics, Inc. Bedford, MA Aug 14, 2015 $108,000
GPV Alliance Management & Regulatory Affairs Specialist/Expert Bayer Healthcare Pharmaceuticals Morristown, NJ Nov 29, 2016 $105,368
Staff Regulatory Affairs Specialist Stryker Medical, A Division of Stryker Corporation Portage, MI Sep 03, 2015 $79,741
Staff Regulatory Affairs Specialist Stryker Medical, A Division of Stryker Corporation Portage, MI Sep 06, 2016 $79,741
Regulatory Affairs Operations Specialist, Submissions Merrimack Pharmaceuticals, Inc. Cambridge, MA Sep 16, 2015 $79,439
Regulatory Affairs Integrated Resources, Inc. Lexington, MA Aug 18, 2016 $79,306
Regulatory Affairs Scientist Mars Petcare Us, Inc. Franklin, TN Apr 03, 2016 $79,000 -
$118,400
Safety Data/Regulatory Affairs Specialist The Fountain Group LLC Parsippany-Troy Hills, NJ Sep 13, 2015 $78,596
Regulatory Affairs Specialist I Boston Scientific Corporation Maple Grove, MN Aug 09, 2016 $65,598
Senior Regulatory Affairs Specialist Cognizant Technology Solutions U.S. Corporation Teaneck, NJ Mar 24, 2015 $65,499
Quality Analyst/Regulatory Analyst Prowess It Solutions LLC Metuchen, NJ Sep 01, 2015 $65,083
IZ Regulatory Affairs Specialist Biomune Company Lenexa, KS Aug 15, 2015 $65,000
Regulatory Affairs Specialist Belcher Pharmaceuticals, LLC Largo, FL Aug 09, 2016 $65,000 -
$75,000
Regulatory Affairs Specialist/Product Complaints Isolvers Inc. Madison, WI Aug 09, 2016 $65,000
Regulatory Affairs Specialist Isolvers Inc. Madison, WI Sep 14, 2016 $65,000

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Top Skills for A Regulatory Affairs Specialist

  1. Ensure Compliance
  2. FDA
  3. Regulatory Documents
You can check out examples of real life uses of top skills on resumes here:
  • Facilitate the development of appropriate and timely responses to regulatory authority queries and actions to ensure compliance with company procedures.
  • Chaired and prepared necessary information for Quality Management Systems, meeting both FDA and ISO requirements for Management Responsibility.
  • Improved Clinical Research progress and prevented data errors by managing and submitting all regulatory documents in accordance to FDA guidelines.
  • Provide strategic direction and operational management of the Regulatory Affairs and Compliance staff in order to successfully navigate the regulatory process.
  • Conduct all study-related correspondence throughout the life of the study, including amendments, safety reports and annual protocol reviews.

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Top 10 Best States for Regulatory Affairs Specialists

  1. District of Columbia
  2. California
  3. Connecticut
  4. Minnesota
  5. Massachusetts
  6. Alaska
  7. Rhode Island
  8. Vermont
  9. Delaware
  10. Washington
  • (59 jobs)
  • (560 jobs)
  • (34 jobs)
  • (97 jobs)
  • (271 jobs)
  • (4 jobs)
  • (12 jobs)
  • (8 jobs)
  • (23 jobs)
  • (69 jobs)

Regulatory Affairs Specialist 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 4,675 Regulatory Affairs Specialist 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 Specialist Resume

View Resume Examples

Regulatory Affairs Specialist Demographics

Gender

Female

55.9%

Male

32.9%

Unknown

11.2%
Ethnicity

White

57.3%

Hispanic or Latino

16.2%

Black or African American

11.2%

Asian

11.2%

Unknown

4.1%
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Foreign Languages Spoken

Spanish

44.5%

French

11.9%

Chinese

5.5%

Japanese

5.5%

Mandarin

4.6%

German

3.7%

Portuguese

3.2%

Arabic

3.2%

Russian

2.8%

Italian

2.3%

Hindi

1.8%

Polish

1.8%

Korean

1.4%

Vietnamese

1.4%

Urdu

1.4%

Cantonese

1.4%

Turkish

0.9%

Gujarati

0.9%

Carrier

0.9%

Dakota

0.9%
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Regulatory Affairs Specialist Education

Schools

Northeastern University

18.8%

University of Phoenix

14.2%

Florida State University

5.5%

George Washington University

5.1%

Johns Hopkins University

4.5%

Temple University

4.3%

American University

4.3%

University of Houston

4.2%

University of Southern California

3.8%

LIU Brooklyn

3.6%

Michigan State University

3.4%

Pennsylvania State University

3.4%

University of Utah

3.4%

Strayer University

3.4%

University of Florida

3.2%

Drexel University

3.2%

New York University

3.0%

University of California - Berkeley

3.0%

Ashford University

3.0%

Fairleigh Dickinson University

3.0%
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Majors

Business

25.0%

Pharmacy

9.5%

Biology

8.6%

Law

8.3%

Psychology

4.5%

Finance

4.5%

Management

4.4%

Health Care Administration

4.4%

Chemistry

4.1%

Accounting

3.7%

Political Science

3.2%

Criminal Justice

3.0%

Environmental Science

2.4%

Nursing

2.2%

Communication

2.2%

Economics

2.1%

Legal Support Services

2.1%

Legal Research And Advanced Professional Studies

2.0%

Marketing

1.9%

Public Health

1.8%
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Degrees

Bachelors

39.4%

Masters

28.8%

Other

12.4%

Doctorate

7.7%

Associate

6.0%

Certificate

4.8%

Diploma

0.6%

License

0.3%
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