Associate Director Global Regulatory Affairs

Job Title: Labeling Strategist
Location: Cambridge MA
Duration: Long Term
Industry: Biopharmaceutical / Pharmaceutical
Hybrid position - 2 days onsite

Job Description 

We are seeking an experiencedAssociate Director, Global Regulatory Affairs – Labeling Lead to lead global labeling strategy and lifecycle management, with a primary focus onbiologics. The ideal candidate will have strong experience developingTarget Label Profiles (TLPs) and leading labeling strategies forCompany Core Data Sheets (CCDS), U.S. Prescribing Information (USPI), and Summary of Product Characteristics (SmPC) updates. Experience withplasma-derived products is a plus.

The Labeling Strategist will lead cross-functionalLabel Working Groups, drive alignment across stakeholders, develop labeling recommendations, and present proposals to theGlobal 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.