Director, Regulatory Labeling Strategy (Remote-Eligible)

Role: Lead global regulatory labeling strategy for marketed biopharma products, overseeing the development and lifecycle management of product labels, including CCDS and regional prescribing and patient info for key markets. Responsibilities: ensure compliance with labeling governance, lead labeling working groups, advise stakeholders on regulatory requirements, and manage health authority interactions regarding labeling. May lead therapeutic area strategies and lifecycle updates. Requirements: Bachelor's degree with 10+ years in regulatory affairs, specifically in global labeling or related disciplines; proven experience in labeling development and negotiations for initial marketing applications or indication expansions; strong knowledge of regulatory labeling requirements across major authorities (FDA, EMA, Health Canada). HighValue: expertise in CCDS and global labeling lifecycle management, regulatory negotiations, and health authority interactions; knowledge of emerging technologies like structured content management, AI, and eLabeling. WorkSetup: remote-eligible with options for hybrid or on-site; no travel specified.