Senior Director, CMC Regulatory Strategy

Job Summary

Serving as a senior advisor in a remote permanent position, the Senior Director, CMC Regulatory Strategy will lead complex regulatory initiatives for biotechnology and pharmaceutical clients, guiding global submission strategies and driving successful product development programs.

Key responsibilities:

• Lead the development and execution of global CMC regulatory roadmaps across various stages of product development
• Act as a primary consultant, providing strategic direction for regulatory agency interactions and submission planning
• Oversee the preparation and review of regulatory documentation, including IND submissions and lifecycle management activities

Required qualifications:

• Bachelor's degree in a scientific discipline; advanced scientific or regulatory degree preferred
• 15+ years of experience in Regulatory Affairs, CMC, Quality, or related fields
• Prior experience within a CRO, regulatory consulting organization, or pharmaceutical/biotechnology company
• Deep expertise in CMC regulatory strategy and FDA regulations
• Proven leadership experience managing senior-level regulatory professionals