Director of Regulatory CMC

Job Summary

Leading the strategic development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies, the full-time Director of Regulatory CMC will manage clinical trial applications and marketing authorizations while ensuring compliance with global health authority regulations in a remote work environment.

Key responsibilities

• Lead the development and lifecycle management of global Regulatory CMC strategies for clinical-stage and commercial products
• Oversee the preparation and delivery of high-quality CMC sections for regulatory submissions, including INDs, CTAs, and NDAs/MAAs
• Direct interactions with regulatory authorities and ensure alignment with cross-functional teams on CMC regulatory risks and submission timelines

Required qualifications

• Advanced degree in chemistry, pharmaceutical sciences, chemical engineering, or related discipline with 10+ years of pharmaceutical industry experience
• Substantial experience in Regulatory CMC with proven ability to lead global regulatory strategy and submissions
• Strong understanding of global Regulatory CMC requirements, including ICH guidelines and FDA, EMA, NMPA expectations
• Expertise in small molecule drug development and commercialization, including lifecycle management activities
• Advanced proficiency in authoring and reviewing CMC regulatory submission documents and briefing materials