Regulatory Specialist Resume Example & Writing Guide

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

Regulatory specialists are responsible for ensuring that their organization is in compliance with government regulations and standards. They’re also tasked with monitoring current regulations and anticipating future ones.

If you’re interested in working in a fast-paced environment where you can have a direct impact on your company’s success, then regulatory specialist might be the perfect role for you.

Here are some tips plus an example to help you write a compelling regulatory specialist resume that hiring managers will love.

James Smith
Houston, TX | (123) 456-7891 | [email protected]

Highly experienced and successful regulatory specialist with a deep understanding of the financial services industry. Proven ability to develop and implement policies and procedures that ensure compliance with all applicable regulations. Excels at collaborating with cross-functional teams to drive results.

University of Texas at Austin Jun '10
B.S. in Biology
Company A, Regulatory Specialist Jan '17 – Current
  • Assisted with the preparation of regulatory submissions and ensured that all applicable regulations were followed in accordance with company policies and procedures.
  • Provided support to project teams by conducting research, preparing documents for review, and providing general administrative support as needed.
  • Coordinated meetings, conference calls, travel arrangements, etc., within the organization or externally when necessary.
  • Maintained current knowledge of new laws/regulations affecting the business area through training sessions and updates from management.
  • Performed other duties as assigned related to Regulatory Affairs including but not limited to assisting with audits, responding to document requests from external parties (e.g., FDA), maintaining records pertaining to regulated products (e.g., INDs).
Company B, Regulatory Specialist Jan '12 – Dec '16
  • Served as the primary point of contact for all regulatory agency inquiries and complaints, resolving them in a timely manner
  • Conducted research on new regulations or changes to existing ones, ensuring that company policies were up-to-date with current laws
  • Prepared detailed reports summarizing findings from investigations into potential violations of regulation compliance requirements
  • Developed training materials for employees on how to comply with federal regulations and state law
  • Collaborated with other departments to ensure that company operations remained compliant with applicable rules and statutes
Company C, Compliance Coordinator Jan '09 – Dec '11
  • Monitored and reported on compliance with regulatory requirements and internal policies and procedures.
  • Conducted regular audits of compliance-related data and documentation.
  • Trained employees on compliance-related topics and provided updates on changes to regulations.
  • Certified Quality Auditor
  • Certified Hazardous Materials Manager
  • Certified Environmental Manager

Industry Knowledge: HIPAA, HITECH, Omnibus Final Rule, MACRA, Stark Law, Anti-Kickback Statute, PHIPA, Stark Law
Technical Skills: Microsoft Office Suite
Soft Skills: Communication, Attention to Detail, Problem Solving, Teamwork, Leadership

How to Write a Regulatory Specialist Resume

Here’s how to write a regulatory 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 “reviewed regulations,” you could say you “reviewed Food and Drug Administration regulations for new drug application and provided feedback to legal department on potential issues.”

The second bullet point is much stronger because it provides specific details about what you did and the results of your work. It also includes a quantifiable result (provided feedback to legal department).

Identify and Include Relevant Keywords

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

One way to make sure you have the right keywords on your resume is to read through the job description and take note of the terms that are used most frequently. Then, use those same words throughout your resume in relevant places like the work experience, skills, summary, and education.

  • Regulatory Affairs
  • Regulatory Submissions
  • Good Clinical Practice (GCP)
  • Regulatory Requirements
  • Clinical Trial Management System (CTMS)
  • Clinical Development
  • Electronic Data Capture (EDC)
  • Clinical Trials
  • Standard Operating Procedure (SOP)
  • Oncology
  • Biotechnology
  • Clinical Research
  • Good Manufacturing Practice (GMP)
  • Life Sciences
  • U.S. Food and Drug Administration (FDA)
  • Regulatory Affairs Management
  • Quality System
  • Pharmacovigilance
  • CMC
  • Clinical Data Management
  • Chemistry
  • Polymers
  • Scientific Writing
  • Microbiology
  • Molecular Biology
  • Project Management
  • Management
  • Strategic Planning
  • Analytical Skills
  • Microsoft Access

Showcase Your Technical Skills

In order to be successful in this role, it is essential that regulatory specialists are proficient in a variety of technical systems and procedures. Recruiters are looking for regulatory specialists who are skilled in programs like Microsoft Office Suite, ERP systems, and manufacturing software. Additionally, it is important that regulatory specialists are familiar with government regulations related to their industry, as they will often be responsible for ensuring that the organization is in compliance with these regulations.


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