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.
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.