Regulatory CMC Director

Job Summary

Providing strategic and operational support for Regulatory CMC activities, the full-time remote Regulatory CMC Director will develop and execute global regulatory strategies for small molecule programs, oversee submissions, and collaborate 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 and technical support across drug substance, drug product, and manufacturing activities to facilitate clinical development and regulatory submissions
• 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
• 8+ years of pharmaceutical industry experience, including at least 5 years in Regulatory CMC roles for small molecule development
• Recent 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, manufacturing processes, and regulatory requirements