Senior Director, Regulatory CMC

Senior Director of Regulatory CMC role at a precision neuromedicine company developing small-molecule therapies. Combines strategic leadership with execution to develop CMC strategies, manage regulatory submissions globally, and build the regulatory function.

Responsibilities

• Develop and execute global regulatory CMC strategies across development programs from early stage through commercialization
• Lead cross-functional teams as Regulatory CMC lead, providing strategic guidance on CMC, manufacturing, analytical, quality, and lifecycle activities
• Prepare, review, and coordinate CMC content and strategy for global regulatory submissions and applications
• Support FDA, EMA, and global health authority interactions including meeting preparation and regulatory responses
• Evaluate CMC changes and provide risk-based regulatory recommendations; build and develop the Regulatory CMC function

Requirements

• Bachelor's degree in scientific discipline; advanced degree preferred
• 12+ years regulatory CMC experience in biotech or pharma with late-stage and global registration work
• Deep understanding of CMC development, manufacturing, analytical, quality, and regulatory considerations
• Experience developing global CMC strategies across multiple development stages
• Led or supported CMC content for INDs, IMPDs, and marketing applications including CTD Module 3
• Contributed to at least one NDA or MAA through submission and Health Authority review
• Strong knowledge of FDA, EMA, ICH, and global CMC requirements and Health Authority interactions