Regulatory Affairs Project Manager
Location: Cincinnati, Ohio
Department: Regulatory Affairs
Job ID: 11546
Job Summary
Medpace is expanding rapidly, and we are seeking a full-time, office-based Regulatory Project Manager to join our Cincinnati team.
As a key member of the Regulatory Affairs department, you will manage and coordinate regulatory submissions, facilitate communication between Sponsors and regulatory agencies, and contribute to the success of global drug development projects.
This role provides an opportunity to leverage your regulatory expertise and advance your career in the clinical research and drug development industry.
Key Responsibilities
Serve as the primary point of contact between Sponsors and regulatory agencies (e.g., US FDA).
Coordinate regulatory submissions, including Investigational New Drug (IND) applications.
Track and report project status, ensuring timely delivery and compliance with regulatory requirements.
Plan and lead internal/external meetings — prepare agendas, presentation materials, and meeting minutes.
Collaborate closely with Regulatory Strategy Leads, Medical Writers, Regulatory Document Specialists, and cross-functional teams to execute project plans.
Maintain clear communication with Sponsors; proactively identify challenges and develop strategic solutions.
Represent Regulatory Affairs in clinical operations meetings.
Support departmental initiatives and contribute to process improvements as needed.
Qualifications
Education:
Bachelor’s degree in Life Sciences with a minimum of 2 years of regulatory experience, or
PhD in Life Sciences with applicable regulatory knowledge.
Experience:
Prior experience working with or submitting to the US FDA.
Strong understanding of FDA regulations and the IND application process.
Knowledge of clinical drug and biologic development.
Skills:
Excellent organizational, communication, and project management skills.
Ability to work efficiently in a fast-paced, collaborative environment.
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 a scientific and disciplined approach.
Headquarters: Cincinnati, Ohio
Global Presence: 5,000+ employees across 40+ countries
Therapeutic Areas: Oncology, Cardiology, Metabolic Diseases, Endocrinology, CNS, Anti-viral, Anti-infective
Why Join Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
For over 30 years, Medpace has helped improve the lives of patients and families worldwide. Join a team committed to innovation, quality, and meaningful impact in clinical research.
Cincinnati Campus Perks
Flexible work environment
Competitive compensation and benefits package
Generous PTO (starting at 20+ days)
Company-sponsored employee appreciation events
Health and wellness programs
Community involvement with local nonprofits
Discounts on local sports, gyms, and attractions
Modern, eco-friendly campus with on-site fitness center
Structured career paths and growth opportunities
Discounted tuition for University of Cincinnati online programs
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 qualifications.
If your profile matches our requirements, you will be contacted with details for the next steps in the hiring process.
Apply Now
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