Senior Director, Regulatory Affairs CMC

The Senior Director, Regulatory Affairs CMC will provide strategic and operational leadership to the Regulatory Affairs CMC team. The ideal candidate will need to accurately interpret and discuss CMC data within cross-functional teams and with Health Authorities.

Requirements

• Oversee the development and implementation of all regulatory CMC strategies
• Directly lead the regulatory CMC strategy for assigned projects
• Ensure the effectiveness of the Regulatory CMC team in developing submissions and in working across functions
• Build and manage relationships through active partnering with key internal and external stakeholders
• Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries
• Support regulatory submissions (NDA, MAA, etc.), Briefing Packages, and response documents for Health Authority interactions and address questions/requests
• Effectively manage direct report(s) and provide mentorship to junior professionals

Benefits

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