Vice President, Regulatory Strategy
Job Locations
United States | United States-OH-Cincinnati
Category: Regulatory Affairs
Job Summary
Our clinical and regulatory activities are growing, and we are currently seeking a full-time Head of Regulatory Strategy to join our team. This position is responsible for the interactions with FDA, accountable for the development and implementation of the regulatory strategy for specific Sponsor projects and ensuring that the strategy is designed to deliver a rapid approval. We are seeking a strategic leader with experience in North American (US FDA) regulatory science, and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to influence cross-functional discussions with Sponsors and relevant stakeholders.
Responsibilities
- 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;
- Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.
Qualifications
- 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.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- Hybrid work-from-home options (dependent upon position and level)
- Competitive PTO packages - starting at 20+ days
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Flexible work schedule
- Competitive compensation and benefits package
- Structured career paths with opportunities for professional growth
- Discounts for local businesses
Awards
- Named a Top Workplace in 2024 by The Cincinnati Enquirer
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
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