Hi,
Title: Associate Director Global Regulatory Affairs
Location: Cambridge MA
Hybrid position - 2 days onsite
Duration: Long Term
Industry: Biopharmaceutical / Pharmaceutical
Job Description
We are seeking an experienced Associate Director, Global Regulatory Affairs Labeling Lead to lead global labeling strategy and lifecycle management, with a primary focus on biologics . The ideal candidate will have strong experience developing Target Label Profiles (TLPs) and leading labeling strategies for Company Core Data Sheets (CCDS), U.S. Prescribing Information (USPI), and Summary of Product Characteristics (SmPC) updates. Experience with plasma-derived products is a plus.
The Labeling Strategist will lead cross-functional Label Working Groups , drive alignment across stakeholders, develop labeling recommendations, and present proposals to the Global Labeling Oversight Committee for review and endorsement. The role works closely with a team of four Labeling Strategists, Labeling Operations Leads, and the broader Global Regulatory Affairs organization.
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