Senior Director, Regulatory Affairs, CMC

📋 Description

• Lead Regulatory CMC strategy; Direct the development and execution of global CMC regulatory
• Oversee global regulatory leadership; Serve as the Global Regulatory Lead for a late-stage ADC
• Manage regulatory submissions; Lead the preparation, review, finalization, and maintenance of CMC
• Coordinate health authority interactions; Lead regulatory engagement and responses to health
• Build and develop the team; Lead and mentor a U.S.-based Regulatory CMC team of approximately five
• Drive cross-functional collaboration; Partner with CMC, Manufacturing, Quality, Supply Chain

🎯 Requirements

• Bachelor's degree in a scientific discipline required; a master's degree or PhD is preferred.
• At least 12 years of relevant pharmaceutical or biotechnology industry experience, including
• Demonstrated experience leading one or more antibody-drug conjugate programs through development
• Proven ability to establish and execute global CMC regulatory strategies, coordinate regional
• Strong experience with CMC dossier preparation, regulatory submission management, agency
• In-depth understanding of CMC development, manufacturing processes, product quality, regulatory

🎁 Benefits

• Competitive base salary: Annual compensation ranging from $204,500 to $274,500, depending on
• Annual bonus opportunity: Eligibility to participate in an annual bonus plan for non-commercial
• Equity opportunities: Eligibility for discretionary equity awards and voluntary participation in an
• Comprehensive healthcare: Medical, dental, and vision insurance.
• Retirement savings: Access to a 401(k) retirement plan.
• Flexible spending and savings accounts: Health Savings Account (HSA) and Flexible Spending Account