Associate Director, Global Regulatory, CMC
Moderna
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. #J-18808-Ljbffr Moderna
Vacancy posted 1 day ago
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