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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

  • $64,140

    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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Regulatory Affairs Associate Jobs

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Regulatory Affairs Associate Career Paths

Regulatory Affairs Associate
Senior Associate Senior Analyst Senior Finance Analyst
Assistant Vice President
7 Yearsyrs
Senior Clinical Research Associate Clinical Study Manager
Clinical Project Manager
10 Yearsyrs
Quality Assurance Specialist Licensed Practical Nurse Clinical Research Coordinator
Clinical Research Manager
9 Yearsyrs
Office Manager Licensed Practical Nurse Clinical Research Coordinator
Clinical Study Manager
8 Yearsyrs
Senior Clinical Research Associate Clinical Project Manager
Clinical Trial Manager
10 Yearsyrs
Contractor/Consultant Research Associate Clinical Research Associate
Clinical Trials Specialist
8 Yearsyrs
Quality Assurance Nursing Director
Director Of Clinical Operations
13 Yearsyrs
Regulatory Affairs Specialist Project Manager Product Manager
Director Of Product Development
11 Yearsyrs
Project Manager Program Manager Senior Manager
Director Of Quality
14 Yearsyrs
Regulatory Affairs Manager Quality Assurance
Quality Assurance Manager
9 Yearsyrs
Project Manager Construction Manager Quality Control Manager
Quality Manager
11 Yearsyrs
Senior Associate Business Analyst Quality Assurance Manager
Quality Systems Manager
12 Yearsyrs
Regulatory Specialist Regulatory Affairs Specialist Regulatory Affairs Manager
Regulatory Affairs Director
12 Yearsyrs
Regulatory Affairs Specialist
Regulatory Affairs Manager
9 Yearsyrs
Compliance Specialist Compliance Manager Compliance Director
Regulatory Compliance Director
13 Yearsyrs
Quality Assurance Specialist Regulatory Affairs Specialist Clinical Research Associate
Senior Clinical Research Associate
10 Yearsyrs
Quality Assurance Quality Assurance Manager
Senior Quality Assurance Manager
11 Yearsyrs
Regulatory Affairs Manager Senior Manager Senior Project Manager
Vice President And Manager
10 Yearsyrs
Regulatory Specialist Project Manager Quality Manager
Vice-President Of Quality
15 Yearsyrs
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Do you work as a Regulatory Affairs Associate?

Regulatory Affairs Associate Demographics

Gender

Female

67.3%

Male

30.1%

Unknown

2.6%
Ethnicity

White

56.5%

Hispanic or Latino

14.2%

Asian

12.8%

Black or African American

11.7%

Unknown

4.8%
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Languages Spoken

Spanish

30.4%

French

16.3%

Japanese

7.6%

Mandarin

6.5%

Russian

6.5%

German

6.5%

Korean

3.3%

Telugu

2.2%

Hindi

2.2%

Greek

2.2%

Croatian

2.2%

Chinese

2.2%

Czech

2.2%

Hebrew

2.2%

Polish

2.2%

Hungarian

1.1%

Macedonian

1.1%

Bosnian

1.1%

Thai

1.1%

Italian

1.1%
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Regulatory Affairs Associate Education

Schools

Northeastern University

24.2%

Temple University

9.5%

George Washington University

5.8%

Johns Hopkins University

5.3%

San Diego State University

4.7%

University of Phoenix

4.7%

Georgetown University

4.2%

Capella University

4.2%

University of Florida

3.7%

Harvard University

3.7%

Syracuse University

3.2%

Arizona State University

3.2%

Ohio State University

3.2%

Pennsylvania State University

3.2%

University of Delaware

3.2%

LIU Brooklyn

3.2%

Western Michigan University

3.2%

Villanova University

2.6%

Ashford University

2.6%

University of Southern California

2.6%
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Majors

Pharmacy

19.1%

Biology

14.0%

Business

13.6%

Political Science

6.3%

Law

5.9%

Health Care Administration

4.7%

Chemistry

4.5%

Psychology

3.8%

Nursing

3.2%

Public Health

2.8%

Biomedical Engineering

2.8%

Public Administration

2.8%

Biotechnology

2.7%

Management

2.3%

Education

2.1%

Legal Support Services

2.1%

Human Resources Management

1.9%

Marketing

1.9%

Legal Research And Advanced Professional Studies

1.7%

Project Management

1.7%
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Degrees

Masters

37.6%

Bachelors

35.7%

Other

9.4%

Doctorate

8.2%

Certificate

4.3%

Associate

4.3%

Diploma

0.4%
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Job type you want
Full Time
Part Time
Internship
Temporary

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 Associate II Fresenius USA Marketing, Inc., A Fresenius Medical Care Na Company Waltham, MA Aug 10, 2015 $100,000
Regulatory Affairs Publishing Associate Vividstarts LLC Cambridge, MA May 16, 2016 $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 Bonita Pharmaceuticals, LLC Westland, MI Jan 08, 2016 $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
Senior QA Regulatory Affairs Associate Dxterity Diagnostics Inc. East Rancho Dominguez, CA Sep 23, 2015 $62,000 -
$70,000
Regulatory Associate III Amneal Pharmaceuticals LLC Piscataway, NJ Sep 07, 2015 $62,000
Regulatory Associate II Amneal Pharmaceuticals LLC Piscataway, NJ Sep 14, 2015 $62,000
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 Affair Associate Global Pharma TEK LLC Sunrise, FL Sep 22, 2015 $60,000

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Top Skills for A Regulatory Affairs Associate

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  1. Regulatory Documents
  2. FDA
  3. Compliance
You can check out examples of real life uses of top skills on resumes here:
  • Prepared regulatory documents containing scientific information for timely submission to health agencies ensuring accuracy, completeness and consistency.
  • Provide administrative quality control/quality assurance review of all FDA submissions.
  • Maintained compliance with all Federal and State regulations and requirements resulting in timely reviews and approvals.
  • Maintained positive relationships with SHA-based corporate affiliates and foundations, through outstanding customer relationship management.
  • Performed laboratory research on various projects Helped prepare documents for FDA approval of medical devices/research

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Top Regulatory Affairs Associate Employers

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