Regulatory Affairs Specialist Resume Example & Writing Guide

Use this Regulatory Affairs Specialist resume example and guide to improve your career and write a powerful resume that will separate you from the competition.

Regulatory affairs is an incredibly important part of the pharmaceutical industry. It’s also a great place for people who like to stay on top of trends and stay on their toes.

If you enjoy being in the know, finding solutions to complex problems, and working with your hands (or your head), then you might be a perfect fit for a career in regulatory affairs. But before you can land your dream job, you need a resume that will impress hiring managers. Follow these tips and resume example to write a regulatory affairs specialist resume that hiring managers will love.

Jennifer Thomas
Chicago, IL | (123) 456-7891 | [email protected]

Dedicated, detail-oriented regulatory affairs specialist with a passion for ensuring products meet safety and compliance standards. Proven ability to navigate through complex regulatory landscapes and develop comprehensive submission packages. Experienced in managing cross-functional teams and building positive relationships with key stakeholders.

Roosevelt University Jun '10
M.S. in Regulatory Affairs
Northeastern Illinois University Jun '06
B.S. in Biology
Company A, Regulatory Affairs Specialist Jan '17 – Current
  • Developed and maintained regulatory documents such as CMC, IND, NDA/BLA, MAA, PMA, etc.
  • Reviewed clinical study protocols for completeness of content and adherence to regulations and standards.
  • Assisted in the preparation of responses to FDA requests for additional information on NDAs/BLAs or supplements.
  • Provided support with regard to international submissions (e.g., EMA) including drafting correspondence related to submission requirements and timelines.
  • Supported development projects through coordination of regulatory activities across multiple functional areas within the organization including Clinical Development, Quality Assurance, Manufacturing & Process Sciences, Regulatory Affairs and Business Development.
Company B, Regulatory Affairs Specialist Jan '12 – Dec '16
  • Developed and implemented a process to track all regulatory submissions, resulting in an average of 15% time savings
  • Conducted research on new regulations and ensured compliance with them before releasing products to the market
  • Served as primary contact for FDA inspections, providing guidance on how to comply with regulations
  • Collaborated with marketing team to create product labeling that met all federal requirements
  • Achieved 100% regulatory submission success rate by following up on incomplete submissions
Company C, Regulatory Affairs Coordinator Jan '09 – Dec '11
  • Prepared and submitted regulatory filings to support new product launches and changes to existing products.
  • tracked submissions and maintained compliance with deadlines and guidelines set by regulatory agencies.
  • Coordinated and managed clinical trials by working with internal and external team members to ensure all regulatory requirements were met.
  • Certified Regulatory Affairs Professional (RAC)
  • Certified Quality Auditor (CQA)
  • Certified Manager of Quality/Organizational Excellence (CMQ/OE)

Industry Knowledge: FDA, ISO, GMP, Health Canada, TGA
Technical Skills: Microsoft Office Suite, Word, Excel, PowerPoint, Access, Powerpoint, Excel, Access
Soft Skills: Communication, Teamwork, Leadership, Attention to Detail, Critical Thinking, Problem Solving, Problem Solving

How to Write a Regulatory Affairs Specialist Resume

Here’s how to write a regulatory affairs specialist resume of your own.

Write Compelling Bullet Points

The best way to make your resume stand out is to use specific examples and numbers. So rather than saying you “managed regulatory affairs for new drug application,” you could say that you “managed regulatory affairs for new drug application, resulting in timely approval by FDA and launch of new drug in Q3 2019.”

The second bullet point is much stronger because it provides specific details about what you did and the outcome of your work. And it also includes a specific date when the project was completed.

Identify and Include Relevant Keywords

When you apply for a job as a regulatory affairs specialist, your resume is likely to go through an applicant tracking system (ATS). This program will scan your resume for certain keywords related to the job opening. If your resume doesn’t include enough of the right terms, the ATS might discard your application.

To increase your chances of getting noticed, use this list of commonly used regulatory affairs keywords and terms as a starting point to help you identify the best skills and experience to include on your resume:

  • Regulatory Affairs
  • Regulatory Submissions
  • Good Manufacturing Practice (GMP)
  • Regulatory Affairs Management
  • Life Sciences
  • Regulatory Requirements
  • Clinical Development
  • Regulatory Writing
  • Quality System
  • Biotechnology
  • Quality Management
  • Standard Operating Procedure (SOP)
  • Clinical Trials
  • Data Safety Monitoring Board
  • U.S. Food and Drug Administration (FDA)
  • Validation
  • Chemistry
  • Protocol
  • Healthcare
  • Medical Devices
  • Product Development
  • Document Control
  • Manufacturing
  • Inspection
  • Good Clinical Practice (GCP)
  • Quality Assurance
  • Teamwork
  • Regulatory Coordination
  • R&D
  • Microsoft Access

Showcase Your Technical Skills

As a regulatory affairs specialist, you are responsible for ensuring that your company is compliant with all government regulations. In order to do this, you need to be familiar with the relevant regulations and the systems that the company uses to track compliance. Some of the programs and systems that you may be familiar with include: ERP systems, manufacturing software, quality management systems, and document management systems.


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