Regulatory Affairs Specialist Resume Example
Mid level • Legal
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Skills
Work Experience
Senior Regulatory Affairs Specialist
Pharmaceutical Company
Washington, DC
Lead regulatory strategy for $500M+ drug portfolioManaged 5 successful NDA submissions with no FDA deficiency lettersCoordinate with FDA on pre-submission meetings and guidance requestsEnsure compliance with global regulatory requirements (EMA, PMDA)
Regulatory Affairs Specialist
Medical Device Company
Rockville, MD
Prepared 510(k) submissions for Class II medical devicesMaintained regulatory documentation and design history filesConducted regulatory assessments for product changes
Education
Master of Science in Regulatory Science
University of Maryland
Bachelor of Science in Biology
Johns Hopkins University
Certifications
- RAC (Regulatory Affairs Certification) - RAPS (September 2020)
Resume Stats
Use this template
Start with this resume and customize it with your own information using our AI-powered builder.
Ready to create your Regulatory Affairs Specialist resume?
Use this template as your starting point and let our AI help you customize it perfectly.