Vice President of Regulatory Affairs

Job Summary

A company is looking for a Vice President of Regulatory Affairs.

Key Responsibilities

• Drive the overall regulatory strategy across all active programs, including CMC and clinical regulatory plans
• Lead all CMC regulatory activities, including filing strategy and oversight of manufacturing partners
• Serve as the primary liaison with regulatory agencies globally and manage post-approval regulatory obligations

Required Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline, or equivalent experience
• 18+ years of regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior roles
• Strong CMC regulatory background with expertise in small molecule drug development
• Demonstrated experience in leading regulatory teams and successful agency interactions
• Experience bringing at least one product to regulatory approval and managing post-approval activities