Associate Director, Global Regulatory, CMC

Role: Associate Director, Global Regulatory-CMC, leading regulatory strategies for biologics or small molecules across all lifecycle stages. Responsibilities: develop and implement global CMC regulatory plans for submissions (IND/CTA/BLA/MAA), provide guidance on CMC development, review submission documents, lead interactions with health authorities, assess manufacturing change controls, and support regulatory processes and templates. Requirements: BS/MS/PhD in a relevant scientific field, 8+ years in pharma/biotech with 5+ years focused on biologics CMC, strong knowledge of global CMC regulations, CTD format, and regulatory procedures. Preferred: ability to collaborate cross-functionally, work independently, and communicate effectively. High-value: biologics, regulatory CMC strategy, global submissions, manufacturing change assessment, interaction with health authorities, applicable to late-stage development or post-market biologic products. Work setup: Not specified; location/modality and travel not detailed.