Regulatory Affairs Specialist Resume Example & Writing Guide

Regulatory Affairs Specialist Resume Example
Discover tips and tricks on crafting a top-notch Regulatory Affairs Specialist resume with our writing guide. Get access to an example and boost your career!
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Regulatory Affairs Specialist Resume Sample


Regulatory Affairs Specialist with 5 years of experience in the pharmaceutical industry. Skilled in regulatory strategy development, regulatory submissions, and compliance with FDA regulations.


  • Regulatory Affairs Specialist

    ABC Pharmaceutical Company, New York, NY

    June 2018 - present

    • Develop regulatory strategies for drug development projects.
    • Prepare and submit IND, NDA, and BLA applications to FDA.
    • Ensure compliance with FDA regulations and guidelines.
    • Interact with FDA officials regarding regulatory submissions and queries.
    • Provide regulatory guidance to cross-functional teams.
  • Regulatory Affairs Associate

    XYZ Biotech, Inc., Boston, MA

    January 2016 - May 2018

    • Assisted in the preparation and submission of IND and NDA applications to FDA.
    • Reviewed labeling, advertising, and promotional materials for compliance with FDA regulations.
    • Coordinated with functional teams to ensure proper document management.
    • Maintained and updated regulatory databases.
    • Prepared and submitted electronic submissions to FDA using eCTD format.


  • Master of Science in Regulatory Affairs

    Northeastern University, Boston, MA

    September 2014 - May 2016

  • Bachelor of Science in Biology

    University of Massachusetts, Amherst, MA

    September 2010 - May 2014

Expert Tip

Use Action Verbs

Start your bullet points with action verbs like 'led', 'managed', 'developed', etc. This helps highlight your skills and abilities in an energetic and straightforward way.

Regulatory Affairs Specialist Resume Writing Guide


As a regulatory affairs specialist, you have the responsibility of ensuring that your company complies with all regulatory requirements for the products they produce. Your job is to ensure that all the products meet legal and safety standards, and adhere to government regulations. Having a well-crafted regulatory affairs specialist resume is imperative to landing the job.

How to Write a Regulatory Affairs Specialist Resume

Here are some steps to follow when writing your regulatory affairs specialist resume:

  • Start with a strong summary or objective statement
  • Begin your resume with a strong opening statement that highlights your skills, experience, and what you can bring to the table as a regulatory affairs specialist.

  • Showcase your work experience
  • Highlight your work experience, focusing on your regulatory responsibilities. This should include your ability to prepare and submit regulatory documents, maintain product approvals and registrations as well as establish and maintain relationships with regulatory bodies.

  • Highlight your education
  • Several Regulatory Affairs Specialist jobs require specific degrees, such as a Bachelor's degree in life sciences, health sciences, regulatory affairs, or regulatory science, a Master's degree would be better. Additionally, having a regulatory affairs certification from a recognized body, such as The Regulatory Affairs Certification (RAC), boosts your chances of being selected by employers.

  • Emphasize your soft skills
  • Working in regulatory affairs requires an individual who is detail-oriented, analytical, and excellent in communication. Enumerating your ability to work independently, provide regulatory guidance and stay up to date with regulatory changes would give you an edge in your application.

  • Add keywords
  • Peruse the employer's job postings and incorporate the keywords and terms that align with your expertise and experience. Doing this increases your chances of being selected for an interview.

  • Include any relevant certifications
  • Professional certifications or continued education in regulatory affairs demonstrate your commitment to advancing your career and staying up to date on industry regulations.

  • Proofread your resume
  • Before submitting your application, ensure you thoroughly check for typos and grammatical errors. Remember, your resume gives potential employers the first impression of you.

Following these tips will strengthen your regulatory affairs specialist resume and help you stand out from other applicants.

Common Resume Writing Mistake

Including Irrelevant Information

Your resume should only contain information that's relevant to the job you're applying for. Irrelevant information may distract the hiring manager from your important qualifications.

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