Associate Director, Global Labeling Lead

Role: Global Regulatory Labeling Strategy Lead (Associate Director) for Plasma-Derived Therapies (PDT) R&D, focusing on the development and lifecycle management of product labeling in US and EU markets. Responsibilities: formulate and implement strategic labeling approaches, oversee CCDS, US, and EU labels, ensure compliance with regulatory guidance, lead cross-functional labeling teams, and liaise with regulatory bodies. Drive innovative solutions for labeling content that optimize product safety and efficacy communication, including combination products. Provide expert advice on labeling requirements and contribute to global labeling strategies for developmental and marketed plasma-derived biologics. Requirements: 7-10+ years in biopharma, with 5-7+ years in global, US, or EU labeling roles; deep understanding of pharmaceutical and device labeling regulations, especially in plasma-derived therapies; bachelor’s or master’s degree, preferably with scientific or health sciences background. Preferred: experience with biologics, combination products, and electronic labeling systems. High-Value: focus on biologics and plasma-derived therapies, involvement in global regulatory strategies, and cross-functional leadership in a hybrid Cambridge, MA setting with global scope.