Labeling Strategist

Role: Senior Labeling Strategist responsible for developing and maintaining global product labeling strategies and documents across therapeutic areas, including Oncology, Inflammation, and Rare Diseases. Core responsibilities include leading the creation of core labeling documents (e.g., Core Data Sheet, US Prescribing Information), chairing labeling working groups, providing strategic guidance on labeling regulations, managing complex labeling projects, and ensuring compliance with global regulatory standards. The role involves cross-functional collaboration with global regulatory teams, contribution to regulatory submissions, and oversight of labeling changes throughout the product lifecycle. Requirements: Doctorate (PhD, MD, or PharmD) with at least 2 years, or Master’s with 4 years, or Bachelor’s with 6 years of relevant experience; extensive regulatory affairs knowledge, familiarity with global labeling requirements (FDA, EMA), and experience with regulatory information management systems. Preferred qualifications include a life sciences or medical degree, prior pharmaceutical industry experience in regulatory affairs or product labeling, and expertise in specific therapeutic areas. The position demands strong project management, technical writing, negotiation, and leadership skills, with 10% travel expected. The work setup is not explicitly specified but involves global regulatory collaboration.