Global Regulatory CMC Lead

Role: Associate Director, Global Regulatory CMC, overseeing regulatory strategies and submissions for biologics across all lifecycle stages. Responsibilities: develop and implement global CMC strategies for submissions (IND/CTA/BLA/MAA), guide product teams on regulatory aspects, review regulatory documents, lead interactions with health authorities, assess manufacturing change controls, and support regulatory process development. Requirements: BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, or related field; 8+ years in pharma/biotech, with 5+ years focused on biologics Regulatory CMC; strong knowledge of global CMC regulations, CTD format, and legislation; excellent communication skills and ability to collaborate in a matrix environment. High-Value: biologics, regulatory CMC strategies, global submissions, manufacturing change assessments, cross-functional guidance, experience with drug development and registration processes.