Director, Regulatory Affairs CMC

Corcept is seeking a Director of Regulatory Affairs CMC to lead the preparation of CMC Regulatory documents and manage a high-performing regulatory CMC team. The ideal candidate will have 10+ years of experience in Regulatory Affairs in the biopharmaceutical industry and a proven track record of effective collaboration with Global regulatory agencies.

Requirements

• Effectively maintain and motivate a high-performing regulatory CMC team
• Lead regulatory - CMC intelligence activities
• Provide Regulatory CMC guidance to internal teams and lead cross-functional teams
• Assess the regulatory impact of proposed manufacturing process changes
• Track regulatory CMC commitments and manage ongoing regulatory submissions
• Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off