Senior Director, CMC Regulatory Strategy

Job Summary

Serving as a senior advisor to biotechnology and pharmaceutical clients, the remote Senior Director, CMC Regulatory Strategy will lead complex CMC regulatory initiatives, guide global submission strategies, and drive successful product development programs across multiple therapeutic modalities in a permanent position.

Key responsibilities

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

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