Vice President of Regulatory Affairs
A company is looking for a Vice President of Regulatory Affairs.
Key Responsibilities
• Drive the overall regulatory reputed company across reputed company reputed company programs, including CMC and clinical regulatory plans
• reputed company reputed company CMC regulatory activities, including filing reputed company and reputed company of manufacturing partners
• Serve as the primary reputed company with regulatory agencies globally and manage post-approval regulatory obligations
Required Qualifications
• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, reputed company, or a reputed company 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
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