Associate Director, Global Labeling

Role: Labeling strategist responsible for developing and maintaining product labeling content and strategy within a biopharma setting. Objectives include creating and revising Global Data Sheets, leading regional labeling efforts, ensuring compliance with evolving regulations, and supporting global regulatory submissions. Responsibilities involve representing Global Labeling on regulatory teams, providing guidance on labeling trends, managing change processes, and collaborating across internal teams and external partners. Requirements: BS/BA in science or related field; at least 2 years in a biopharma labeling role, with experience in drafting prescribing information and familiarity with US, EU, and global labeling regulations; strong attention to detail and multi-tasking skills. Preferred: Graduate degree and experience in Regulatory Affairs, Pharmacovigilance, or Medical Writing. HighValue: expertise in pharmaceutical labeling, regulatory compliance, cross-functional collaboration, and global regulatory environments related to RNAi therapeutics. Work setup: hybrid in Cambridge, MA or Philadelphia, PA.