Associate Director, Regulatory Labeling Strategy

Role: Associate Director, Labeling Strategy, overseeing global regulatory labeling for rare disease therapies throughout their lifecycle. Responsibilities: lead cross-functional Labeling Working Group, coordinate labeling approval processes with Executive Labeling Board, author and revise technical product labels (TPL, CCDS, USPI), develop global implementation plans, manage communication updates, and negotiate labeling with health authorities. Ensure compliance with US and EU labeling regulations, interpret guidance, and align local labeling with global standards. Manage structured product labels (SPL), support regulatory submissions, and contribute to process improvements. Collaborate with Regulatory Affairs, Clinical Development, Medical Affairs, and Regulatory Operations. Requirements: Bachelor's in a scientific field; advanced degree preferred; 8+ years in pharma/biotech with at least 6 years in labeling or regulatory roles; strong knowledge of US and EU labeling regulations, experience with global labeling strategies, and familiarity with regulatory submissions (INDs, BLA, MAA). Skills/Qualifications: Excellent project management, strategic thinking, regulatory judgment, cross-functional influence, and communication skills; ability to travel (10%). High-Value Details: Focus on rare disease, biologics or small molecules, supporting development and post-marketing phases, with regulatory and labeling expertise in global markets.