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Become A Regulatory Affairs Associate

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Working As A Regulatory Affairs Associate

  • 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

  • $90,000

    Average Salary

What Does A Regulatory Affairs Associate Do At Kelly Services

* Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
* Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required
* Provide technical interface with FDA and international reviewers and respond to questions
* Provide the appropriate information to support international product registrations
* Provide timely review and approval of product labeling and marketing claims for regulatory compliance
* Provide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
* May supervise and direct Project Team personnel; may provide direction to assistant personnel

What Does A Regulatory Affairs Associate Do At Gilead

* Manage the submission of promotional materials for marketed
* prescription drug products to FDA's Office of Prescription Drug Promotion
* OPDP) at the time of first use.
* With team, manage the submission of subpart
* H and launch advisory submissions to FDA/OPDP.
* Track and adhere to strict
* timelines for FDA/OPDP submissions.
* Collaborate with cross-functional
* partners to ensure the publication of compliant, high-quality, and timely
* FDA/OPDP submissions.
* Train external advertising agencies on Gilead
* submission processes.
* Manage the Regulatory Affairs, Advertising and
* Promotion promotional PI verification process.
* Track and summarize relevant
* internal metrics.
* Essential Duties and Job Functions
* In addition to the responsibilities above,
* this position also requires the ability to:
* Initiate and contribute to local
* process improvements, which have an impact on the working of the Regulatory
* Affairs, Advertising and Promotion group.
* Represent the Regulatory Affairs,
* Advertising and Promotion group in Regulatory Affairs working groups, as
* appropriate.
* Establish and maintain effective working relationships within
* the Regulatory Affairs, Advertising and Promotion group and across the
* Regulatory Affairs organization.
* Participate in group meetings and present
* project status updates to group.
* Help create and maintain internal archives
* for the Regulatory Affairs, Advertising and Promotion group.
* Contribute to
* the monitoring of the Regulatory Advertising and Promotion environment; with
* manager, provide updates to the group on FDA/OPDP notices and enforcement
* letters.
* Support members of the Regulatory Affairs, Advertising and Promotion
* group by conducting Regulatory specific research, including FDA/OPDP
* enforcement precedent.
* Knowledge, Experience and Skills
* BS or BA degree required.
* years of
* relevant industry experience in Regulatory Affairs or related discipline

What Does A Regulatory Affairs Associate Do At Lilly

* Prepare regulatory submissions to FDA and other agencies, with direction from the Senior Director, Regulatory Affairs
* Coordinate/manage the review and approval process of senior management of the company for all regulatory submissions on company development compounds
* Electronically archive and catalog all submissions to and communications with regulatory agencies
* Maintain Avid entries in clinical trial registries including clinicaltrials.gov
* Provide administrative support to projects of other departments in the company, such as Quality Assurance, Chemical Development and Manufacturing, and Operations/contract management, as required

What Does A Regulatory Affairs Associate Do At Johnson Matthey Pharma Services

* Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7, M4 and related guidance, FDA regulations, etc.
* Provides technical knowledge to all departments when developing regulatory policies and procedures.
* Ensures site regulatory policies and procedures are compliant with state and federal requirements, including but not limited to GMP, DEA, FDA, etc.
* Reviews all investigations and documentation to ensure compliance with Johnson Matthey’s Standard Operating Procedures (SOPs), all state and federal regulations.
* Provides guidance to all departments on regulatory-related issues.
* ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES
* Is knowledgeable in the understanding of all EH&S policies and procedures.
* Ensures that all job activities comply with any EH&S related rules and regulations that pertain to the department.
* Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2017 principals into daily activities

What Does A Regulatory Affairs Associate Do At Novartis Pharmaceuticals

* Publish and archive ANDAs, NDAs, INDs, DMFs, annual reports and safety reports.
* Utilize Electronic Submission Gateway (ESG) to submit submissions to FDA centers such as CDER, CBER, and OC.
* Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements.
* Ensures that documents are formatted and named in accordance with FDA, ICH guidelines & internal guidelines/SOPs.
* Responsible for ensuring the compliance of drug listing, establishment registration and Self
* ID with FDA.
* Utilize tools for document management, tracking, publishing and eCTDs.
* Act as first level help desk to provide general support with respect to processes and operational activities (i.e. SPL, eCTD or any other use system/ processes).
* Resolve publishing and submission issues.
* Engage in life cycle management of submission documents (if necessary) to ensure document integrity.
* Track and monitor metrics, maintains submission tracking tool.
* Escalates issues to Regulatory Management as appropriate and maintain open dialog.
* Assists Regulatory Operations Team to evaluate changes in health authority requirements for eCTD and SPL submissions and implements changes to workflow processes.
* Preparation of SOPs, working instructions and training material per department process and systems as needed

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Average Yearly Salary
$90,000
View Detailed Salary Report
$49,000
Min 10%
$90,000
Median 50%
$90,000
Median 50%
$90,000
Median 50%
$90,000
Median 50%
$90,000
Median 50%
$90,000
Median 50%
$90,000
Median 50%
$166,000
Max 90%
Highest Paying City
San Rafael, CA
Highest Paying State
North Dakota
Avg Experience Level
2.3 years
How much does a Regulatory Affairs Associate make at top companies?
The national average salary for a Regulatory Affairs Associate in the United States is $90,664 per year or $44 per hour. Those in the bottom 10 percent make under $49,000 a year, and the top 10 percent make over $166,000.

Real Regulatory Affairs Associate Salaries

Job Title Company Location Start Date Salary
Regulatory Affairs Therapeutic Area Associate Director Novartis Institutes for Biomedical Research, Inc. Cambridge, MA Mar 08, 2016 $140,000
Principal Regulatory Affairs Associate-Pharma Fresenius USA Marketing, Inc., A Fresenius Medical Care Na Company Waltham, MA Jan 10, 2016 $127,502
Senior Regulatory Affairs Associate Thoratec Corporation Pleasanton, CA Sep 14, 2015 $112,000 -
$123,600
Regulatory Affairs Associate II Devices Fresenius USA Marketing, Inc., A Fresenius Medical Care Na Company Waltham, MA Apr 01, 2016 $105,000
Global Regulatory Affairs Associate, Senior Genzyme Corporation Cambridge, MA Jul 25, 2016 $101,067 -
$102,566
Regulatory Affairs Publishing Associate Vividstarts LLC Cambridge, MA May 16, 2016 $100,000
Regulatory Affairs Associate II Fresenius USA Marketing, Inc., A Fresenius Medical Care Na Company Waltham, MA Aug 10, 2015 $100,000
Regulatory Affairs Associate Principal Genzyme Corporation Cambridge, MA Jul 09, 2016 $98,924 -
$148,386
SR. Regulatory Affairs Associate Gilead Sciences, Inc. Seattle, WA Sep 10, 2015 $97,000
Senior Regulatory Affairs Associate Stealth Biotherapeutics Inc. Newton, MA Aug 31, 2015 $92,000 -
$102,000
Regulatory Affairs Associate III Anchen Pharmaceuticals, Inc. Irvine, CA Dec 17, 2015 $91,354 -
$110,000
Regulatory Affairs Associate Edwards Lifesciences LLC Irvine, CA May 07, 2016 $91,354
Regulatory Affairs Associate Par Pharmaceutical Spring Valley, NY Jul 30, 2015 $90,000
Regulatory Affairs Associate II Amneal Pharmaceuticals LLC Piscataway, NJ Mar 10, 2016 $78,000
Regulatory Affairs Associate Alvogen, Inc. Brookfield, NJ Feb 29, 2016 $78,000
Senior Regulatory Affairs Associate DR. Reddy's Laboratories, Inc. Princeton, NJ Jan 10, 2016 $78,000
Senior Regulatory Affairs Associate Lannett Company, Inc. Philadelphia, PA Oct 23, 2015 $77,210
Regulatory Affairs Associate TEVA Pharmaceuticals USA, Inc. Parsippany-Troy Hills, NJ Jun 12, 2016 $76,000
Senior Regulatory Affairs Associate Lupin Pharmaceuticals, Inc. Baltimore, MD Feb 12, 2016 $75,863
Associate 2, Regulatory Affairs International Biomarin Pharmaceutical, Inc. San Rafael, CA Aug 26, 2015 $75,000
Regulatory Affairs Associate Alkermes, Inc. Waltham, MA Jan 25, 2016 $75,000 -
$85,000
Regulatory Affairs Associates Novel Laboratories, Inc. Somerset, NJ Jan 10, 2015 $62,000
Regulatory Associate II Amneal Pharmaceuticals LLC Piscataway, NJ Sep 14, 2015 $62,000
Regulatory Associate III Amneal Pharmaceuticals LLC Piscataway, NJ Sep 07, 2015 $62,000
Senior QA Regulatory Affairs Associate Dxterity Diagnostics Inc. East Rancho Dominguez, CA Sep 23, 2015 $62,000 -
$70,000
SR. Regulatory Affairs Associate Novel Laboratories, Inc. Somerset, NJ Aug 26, 2016 $61,693 -
$71,000
SR. Regulatory Affairs Associate Amneal Pharmaceuticals of Ny, LLC Hauppauge, NY May 01, 2016 $61,069
Senior Regulatory Affairs Associate Amneal Pharmaceuticals LLC Piscataway, NJ Feb 09, 2015 $61,053
Regulatory Affairs Associate Global Pharma TEK, LLC Cary, NC Sep 13, 2016 $60,000

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Top Skills for A Regulatory Affairs Associate

  1. FDA
  2. Regulatory Documents
  3. NDA
You can check out examples of real life uses of top skills on resumes here:
  • Maintained existing approvals with timely and accurate reporting to FDA prepared under supervision.
  • Identify, obtain, compile and review regulatory documents for regulatory submissions, striving for quality submissions and expedited approvals.
  • Review of Batch Manufacturing Records, Standard Operating Procedures and other Quality Documents.
  • Provided consulting services that include protocol development, preparation of IRB submissions and regulatory affairs oversight.
  • Review all promotional, advertising and labeling materials to ensure compliance with all federal regulations and adherence to company policies.

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Top 10 Best States for Regulatory Affairs Associates

  1. California
  2. Massachusetts
  3. District of Columbia
  4. Connecticut
  5. Minnesota
  6. Washington
  7. Alaska
  8. Delaware
  9. Texas
  10. New Jersey
  • (523 jobs)
  • (250 jobs)
  • (44 jobs)
  • (23 jobs)
  • (92 jobs)
  • (62 jobs)
  • (2 jobs)
  • (18 jobs)
  • (101 jobs)
  • (186 jobs)

Regulatory Affairs Associate Demographics

Gender

Female

60.2%

Male

27.6%

Unknown

12.2%
Ethnicity

White

55.7%

Hispanic or Latino

14.3%

Asian

13.4%

Black or African American

11.7%

Unknown

4.9%
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Foreign Languages Spoken

Spanish

35.3%

French

14.3%

Mandarin

6.7%

Japanese

6.7%

Russian

5.9%

German

5.9%

Korean

3.4%

Hindi

2.5%

Chinese

2.5%

Czech

2.5%

Telugu

1.7%

Greek

1.7%

Croatian

1.7%

Portuguese

1.7%

Slovak

1.7%

Hebrew

1.7%

Polish

1.7%

Marathi

0.8%

Gujarati

0.8%

Hungarian

0.8%
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Regulatory Affairs Associate Education

Schools

Northeastern University

26.0%

Temple University

10.5%

University of Phoenix

5.6%

LIU Brooklyn

5.6%

George Washington University

5.3%

Johns Hopkins University

4.7%

Georgetown University

4.1%

Ohio State University

3.8%

San Diego State University

3.8%

American University

3.8%

Fairleigh Dickinson University

2.9%

Arizona State University

2.9%

University of Southern California

2.9%

Boston University

2.9%

University of Florida

2.6%

Columbia University

2.6%

Capella University

2.6%

University of North Carolina at Chapel Hill

2.6%

Pennsylvania State University

2.3%

Harvard University

2.3%
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Majors

Pharmacy

21.7%

Business

15.0%

Biology

12.7%

Political Science

6.0%

Law

5.4%

Health Care Administration

4.6%

Chemistry

4.0%

Psychology

3.8%

Nursing

2.8%

Public Health

2.7%

Biomedical Engineering

2.7%

Management

2.4%

Marketing

2.4%

Biotechnology

2.3%

Biochemistry, Biophysics, Molecular Biology

2.0%

International Relations

2.0%

Communication

1.9%

Public Administration

1.8%

Finance

1.8%

Legal Research And Advanced Professional Studies

1.6%
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Degrees

Masters

37.6%

Bachelors

37.1%

Other

8.8%

Doctorate

8.0%

Certificate

4.1%

Associate

4.0%

Diploma

0.5%

License

0.1%
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