Job Title: FDA Regulatory Expert
Location: United States
Department: Regulatory Affairs
Job ID: 11295
Employment Type: Full-time
Job Summary
Medpace is seeking a full-time FDA Regulatory Strategist to join our growing clinical and regulatory team. This position is responsible for leading interactions with the FDA and developing regulatory strategies for Sponsor projects, ensuring rapid approval. The ideal candidate is a strategic leader with expertise in US FDA regulatory science, drug/biologic development, and therapeutic areas to influence cross-functional discussions with Sponsors and stakeholders.
Key Responsibilities
Provide expert regulatory strategy aligned with industry standards, applying in-depth knowledge of regulatory requirements, guidelines, procedures, and agency precedent.
Advise Sponsors and project teams on development and implementation of regulatory strategies throughout clinical development.
Collaborate with cross-functional teams on strategic projects, including:
Gap analyses
Meetings with regulatory authorities
Protocol synopsis development and review
Other strategic deliverables
Qualifications
Education: MD, PhD in Life Sciences, or other advanced degree.
Experience:
Minimum of 5 years in regulatory drug development or equivalent experience.
Expert knowledge of regulatory affairs within one or more therapeutic areas.
Professional experience at the FDA (e.g., Medical Reviewer, Clinical Team Leader, or Division Director) is preferred.
About Medpace
Medpace is a full-service clinical CRO providing Phase I-IV clinical development services to biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, with over 5,000 employees across 40+ countries, Medpace accelerates the global development of safe and effective medical therapeutics using a scientific and disciplined approach. Therapeutic expertise includes:
Oncology
Cardiology
Metabolic Disease
Endocrinology
Central Nervous System
Anti-viral & Anti-infective
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow.
Positive impact on patients and families worldwide.
Flexible work environment
Competitive PTO packages (starting at 20+ days)
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Competitive compensation and benefits package
Structured career paths for professional growth
Discounts for local businesses
Awards & Recognition
Named a Top Workplace in 2024 by The Cincinnati Enquirer
Recognized by Forbes as one of America's Most Successful Midsize Companies (2021–2024)
CRO Leadership Awards from Life Science Leader magazine
Next Steps
A Medpace team member will review your qualifications and, if interested, contact you with details for next steps.
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