Senior Director, Regulatory CMC

Job Summary

Providing strategic and operational leadership, the full-time remote Senior Director, Regulatory CMC will manage Regulatory CMC activities for small molecule development programs, overseeing global regulatory strategies and submissions while collaborating with internal and external stakeholders.

Key responsibilities

• Develop and execute integrated Regulatory CMC strategies for small molecule programs from preclinical development through regulatory submissions
• Provide strategic leadership across drug substance, drug product, and analytical development to support clinical development and commercialization
• Serve as the Regulatory CMC subject matter expert on cross-functional teams, ensuring alignment with clinical, regulatory, and business objectives

Required qualifications

• Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline; PharmD or PhD preferred
• Minimum of 12 years of pharmaceutical industry experience, with at least 5 years in Regulatory CMC roles for small molecule programs
• Direct experience leading Regulatory CMC activities for late-stage development programs and marketing application submissions
• Proven experience with CMC regulatory filings, including INDs, IMPDs, and NDAs
• Strong knowledge of small molecule drug development, cGMP requirements, and global Regulatory CMC expectations