FDA Regulatory Expert
Location: United States
Department: Regulatory Affairs
Job ID: 11295
Job Summary
Medpace is expanding its clinical and regulatory operations and is seeking a full-time FDA Regulatory Strategist to join our Regulatory Affairs team.
This role focuses on strategic regulatory interactions with the U.S. FDA, leading the development and implementation of regulatory strategies for Sponsor projects to ensure efficient and timely product approvals.
We are looking for a strategic leader with deep expertise in U.S. FDA regulatory science and the overall drug/biologic development process. Strong knowledge of therapeutic areas and development strategies is vital to effectively guide cross-functional teams and Sponsor collaborations.
Key Responsibilities
Develop and execute regulatory strategies aligned with FDA expectations and industry standards.
Apply in-depth knowledge of regulatory requirements, guidelines, procedures, and agency precedents.
Provide expert advice to Sponsors and internal teams throughout clinical development.
Lead and collaborate on cross-functional projects such as:
Regulatory gap analyses
FDA meeting preparations and participation
Protocol synopsis development and review
Other key strategic regulatory deliverables
Qualifications
Education: MD, PhD in Life Sciences, or other advanced degree.
Experience: Minimum 5 years of regulatory drug development experience.
Expertise: In-depth understanding of regulatory affairs in one or more therapeutic areas.
Preferred: Prior professional experience within the U.S. FDA (e.g., Medical Reviewer, Clinical Team Leader, or Division Director).
About Medpace
Medpace is a full-service Clinical Research Organization (CRO) providing Phase I–IV clinical development services to the biotechnology, pharmaceutical, and medical device industries.
Our mission is to accelerate the global development of safe and effective medical therapeutics through scientific excellence and regulatory expertise.
Headquarters: Cincinnati, Ohio
Global Presence: 5,000+ employees across 40+ countries
Therapeutic Areas: Oncology, Cardiology, Metabolic Diseases, Endocrinology, CNS, Anti-viral, and Anti-infective
Why Join Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we do transforms the lives of patients across hundreds of diseases worldwide. Be part of a company that is shaping the future of clinical research and regulatory science.
Medpace Perks
Flexible work environment
Competitive compensation and benefits package
Generous PTO (starting at 20+ days)
Structured career paths and professional growth opportunities
Company-sponsored employee appreciation events
Health and wellness initiatives
Local business discounts
Awards & Recognition
🏆 Top Workplace 2024 – The Cincinnati Enquirer
🥇 Forbes: America’s Most Successful Midsize Companies (2021–2024)
🏅 CRO Leadership Awards – Life Science Leader Magazine (Expertise, Quality, Reliability, Compatibility, Capabilities)
Next Steps
A Medpace recruitment team member will review your application.
If your qualifications match the requirements, you will be contacted regarding the next steps in the hiring process.
Apply Now
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