Executive Director, Regulatory CMC

📋 Description

• Lead global CMC regulatory strategy and submissions.
• Partner with CMC, Quality, Tech Ops, Clinical, and Regulatory leadership.
• Enable product development, licensure, and lifecycle management.
• Define regulatory risks and ensure high-quality documentation.

🎯 Requirements

• PhD in a relevant scientific field; MS/BS with significant experience considered.
• 12–15+ years in CMC regulatory affairs in biotech/pharma.
• Proven track record leading CMC strategy and Module 3 for major submissions.
• Deep knowledge of global CMC regulations (ICH Q-series, regional requirements).
• Strong cross-functional leadership and executive communication.
• Curiosity and adaptability in adopting AI-powered tools.

🎁 Benefits

• Market-competitive rewards package.
• Includes annual performance bonus and equity.
• Generous health benefits.
• Collaborative, mission-driven culture.