Director CMC Regulatory Affairs

Job Summary

Leading the development and implementation of CMC regulatory strategy for small molecule investigational drugs, the remote-friendly Director CMC Regulatory Affairs will manage regulatory submissions, provide strategic advice, and ensure compliance with global regulatory standards across clinical trials.

Key responsibilities

• Develop and implement CMC regulatory strategies for Phase 1-3 clinical trials and marketing applications
• Manage the preparation and review of region-specific CMC submission documents and agency requests
• Deliver high-quality regulatory submissions and support cross-functional teams in navigating regulatory requirements

Required qualifications

• BA/BS, MS, or PhD in a relevant technical discipline; RAC certification preferred
• 8+ years of experience in CMC regulatory affairs for drug products and drug substances
• Deep technical knowledge of small molecule drug development and worldwide CMC regulatory standards
• Experience authoring high-quality INDs, IND amendments, and NDAs with a track record of meeting timelines
• Understanding of US and ex-US regulations and risk management in drug development