Senior Director, CMC Regulatory Strategy

Job Summary

To support a leading global organization, the remote permanent Senior Director, CMC Regulatory Strategy will serve as a senior advisor to biotechnology and pharmaceutical clients, leading complex CMC regulatory initiatives and guiding global submission strategies.

Key responsibilities:

• Lead the development and execution of global CMC regulatory roadmaps for clients 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