Director, Global Labeling Regulatory

Role: Global Labeling Regulatory Director responsible for developing and maintaining product labeling strategies throughout the drug lifecycle, ensuring compliance with international regulatory standards. Responsibilities include managing labeling document preparation (USPI, SmPC), overseeing artwork updates, leading negotiations with regulatory agencies, and managing labeling change controls. Leadership duties involve managing a team, coaching, and performance monitoring. Requirements: Bachelor's in life sciences or technical field with 14+ years of experience, or Master's with 12+ years, with extensive knowledge of global regulatory labeling requirements for biologics, cell and gene therapies, and recombinant proteins. Experience in preparing CMC modules (eCTD) and managing teams preferred. Skills: strong leadership, project management, proficiency with electronic document systems (e.g., Veeva Vault), and attention to cultural sensitivities. High-Value: biologic drugs, cell and gene therapies, regulatory submissions, global health authority compliance, and experience working in complex, matrix environments. WorkSetup: onsite in Summit, NJ, with some flexibility; travel possible for agency meetings, conferences, or manufacturing visits.