Vice President of Regulatory Affairs

Job Summary

Leading the regulatory function for a pioneering veterinary medicine company, the full-time remote Vice President of Regulatory Affairs will manage the overall regulatory strategy, ensuring compliance from early development through approval and post-approval lifecycle management.

Key responsibilities

• Own and drive the regulatory strategy across all active programs, integrating CMC and clinical regulatory plans with development milestones
• Lead all CMC regulatory activities, including filing strategy, post-approval change management, and oversight of manufacturing partners
• Serve as the primary liaison with global regulatory agencies, managing submissions, agency interactions, and compliance obligations

Required qualifications

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent experience
• 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior regulatory leadership roles
• Strong CMC regulatory background with expertise in small molecule drug development and post-approval regulatory activities
• Demonstrated history of successful agency interactions and bringing products to regulatory approval
• Experience building and scaling regulatory organizations in startup or high-growth environments