Vice President, Regulatory Strategy
Medpace
- Cincinnati, OH
- Permanent
- Full-time
- Provide expert regulatory strategy to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures, and agency precedent;
- Advise project teams regarding the development and implementation of regulatory strategy throughout the clinical development processes;
- Collaborate with regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables;
- Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate;
- Interact with appropriate national/regional government regulatory agencies;
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
- Lead a team of physicians and regulatory staff with strategic regulatory expertise; and
- Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.
- MD, PhD in Life Sciences, or other advanced degree.
- Minimum of 5 years of experience or equivalent of regulatory drug development. Expert knowledge of regulatory affairs within one or more therapeutic areas;
- Professional experience working at the FDA such as Clinical Team Leader, preferred;
- Extensive experience working/partnering with FDA required.
- Hybrid work-from-home options (dependent upon position and level)
- Competitive PTO packages, starting at 20+ days
- Flexible work hours
- Discounted tuition for UC online programs
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Community involvement with local nonprofit organizations
- Competitive compensation and benefits package
- Structured career paths with opportunities for professional growth
- Partnership and discount with onsite childcare
- Discounts on local sports games, local fitness gyms and attractions
- Official Sponsor of FC Cincinnati
- Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants
- Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility