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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

  • $61,543

    Average Salary

What Does A Regulatory Affairs Associate Do At Abbvie

* Demonstrates ability to apply CMC, non-clinical and clinical understanding and disease state knowledge in a regulated environment.
* Identifies and communicates routine Health Authorities filing needs.
* Responsible (with manager’s oversight as needed) for educating internal customers on Regulatory issues including clinical development, non-clinical, Discovery, CMC, commercial, public affairs, legal and others who contribute to regulated communication or communications that could be regulated.
* Serve as the Regulatory Affairs representative on key sub-teams
* Maintains thorough knowledge of product data and key product issues across multiple programs.
* Prepares routine submissions in compliance with department and regulatory requirements and guidelines.
* Assists with larger or more complex submissions.
* Functions independently in decision making for routine issues.
* In conjunction with manager, reviews complex issues and problem resolution successes and setbacks to assist in future problem solving applications/options.
* Completes tasks and disseminates pertinent information to appropriate inter-departmental areas.
* Serves as department representative on cross-functional initiatives Responsible for supporting the department, division and company’s strategic direction and goals
* With management guidance participates in the problem solving process by monitoring issues and implementing strategies for resolution.
* Analyzes and interprets information, impacting regulatory decisions
* Consistently exercises good judgment in the application of policies and regulations.
* Works well with other individuals and departments in solving problems

What Does A Regulatory Affairs Associate Do At Kelly Services

* Maintain quality and regulatory document files.
* Gather necessary paperwork and documentation for regulatory filings.
* Create and maintain database of quality & regulatory documents.
* Assist with the annual registration of client's sites with the US FDA.
* Prepare correspondence for regulatory agencies.
* Compile and track changes and oversee regulatory requirements (regulations, guidelines, standards, USP, EP,...) pertaining to the client's products for pharma, food and medical device
* applications.
* Maintain Drug Master File for technical documents.
* Interact with regulatory personnel in different countries.
* Work in an interdisciplinary, intercultural environment

What Does A Regulatory Affairs Associate Do At System One Services

* Plans, coordinates and writes responses to inquiries from the FDA resulting from their review of the submissions.
* Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files
* Reviews technical documents for accuracy and acceptability
* Independently authors, complies and reviews ANDAs, NDAs, Amendments, Supplements and Annual Reports.
* Reviews and signs-off on change control documentation.
* Translates and communicates regulatory requirements and strategies to team members and to internal/external business units

What Does A Regulatory Affairs Associate Do At Fresenius Medical Care North America

* Developing professional expertise; applies company policies and procedures to assist in the day-to-day procedures used to support regulatory submission (drugs and device) and publishing activities.
* Assists in the maintenance of an archiving/document management system.
* Responsible for producing and tracking FMCNA regulatory submissions and submissions-compliant documents in the electronic format (eCTD and eFiling).
* Responsible for assisting in implementing and maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions.
* Works with department and external groups as assigned.
* Participates in the evaluation and provide input for new department technologies and collaborate with intra-departmental resources to ensure adherence to infrastructure standards.
* Compiles, publishes, QC, and validates documents for FDA submission.
* Troubleshoots document issues in MS Word and Adobe Acrobat.
* Provides editing and formatting support.
* Supports the transition from legacy to electronic submissions.
* Coordinates with regulatory staff to compile regulatory submissions.
* Ensures that all required documents are received and formatted appropriately and in a timely manner.
* Demonstrates knowledge of electronic submission requirements and prepares for future initiatives and requirements.
* Participates in a document management system to align document access and storage with RA electronic submission needs.
* Assists in development of overall project timing.
* Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors.
* Exercises judgment within defined procedures and practices to determine appropriate action.
* Builds productive working relationships.
* Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
* Assists with various projects as assigned by direct supervisor.
* Other duties as assigned

What Does A Regulatory Affairs Associate Do At PPD

* Provides regulatory consulting and strategic advice to internal and external clients
* Provides project specific GRA strategy, technical expertise and co-ordination oversight for key client’s projects
* Liaises with PPD globally to support global projects, and ensures quality performance for key/managed projects
* Serve as key clients “Executive” contact person for all issues including attendance at Regulatory Authority meetings and other Public Relation functions
* Manages project budgeting/forecasting
* Assists business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure
* Contributes to development & implementation of Global/regional function/plans
* LI-SH1

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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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Regulatory Affairs Associate Demographics


  • Female

  • Male

  • Unknown



  • White

  • Asian

  • Hispanic or Latino

  • Unknown

  • Black or African American

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Languages Spoken

  • Spanish

  • French

  • Japanese

  • German

  • Mandarin

  • Russian

  • Korean

  • Italian

  • Greek

  • Croatian

  • Chinese

  • Czech

  • Hebrew

  • Polish

  • Telugu

  • Hindi

  • Dutch

  • Hungarian

  • Macedonian

  • Bosnian

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Regulatory Affairs Associate

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Regulatory Affairs Associate Education

Regulatory Affairs Associate

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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 -
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 -
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 -
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 -
Regulatory Affairs Associate III Anchen Pharmaceuticals, Inc. Irvine, CA Dec 17, 2015 $91,354 -
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 -
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 -
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 -
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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Top Regulatory Affairs Associate Skills

  1. FDA
  2. Regulatory Compliance
  3. NDA
You can check out examples of real life uses of top skills on resumes here:
  • Assisted in the preparation and submission of abbreviated new drug applications and annual reports to FDA.
  • Created and reviewed Standard Operating Procedures for the department to ensure Regulatory Compliance.
  • Review incoming proposals, research organizations, assist in recommendations for funding and communicate fund disposition to organizations.
  • Assist in managing regulatory complaints and regulatory affairs databases.
  • Prepare documentation for medical devices and OTC product registration.

Top Regulatory Affairs Associate Employers

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