Director of CMC Regulatory Affairs

Job Summary

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

Key responsibilities

• Develop and implement CMC regulatory strategies for global Phase 1-3 clinical trials and marketing applications
• Deliver high-quality regulatory submissions and manage internal and external contributors for investigational stage CMC documents
• Assess and identify risk mitigation plans based on evolving US and Ex-US GMP regulations and guidance

Required qualifications

• BA/BS, MS, or PhD in a relevant technical discipline with 8+ years of CMC regulatory experience
• Deep technical knowledge of small molecule drug development and extensive command of worldwide CMC regulatory standards
• Experience in authoring high-quality INDs, IND amendments, and NDAs with a proven track record of meeting timelines
• Understanding of US and ex-US regulations, providing strategic advice, and supporting cross-functional teams
• RAC certification preferred