Associate Director, Regulatory Labeling Strategy

Role: Associate Director, Labeling Strategy, responsible for developing and executing global regulatory labeling strategies throughout the product lifecycle for rare disease therapies. Responsibilities: lead cross-functional Labeling Working Group, coordinate with Health Authorities, author and manage labeling documents (USPI, CCDS, TPL), develop global labeling implementation plans, and oversee label negotiations and approval processes. Provide strategic guidance on labeling implications for development and post-marketing activities, ensuring compliance with US and EU regulations, and lead continuous process improvements. Requirements: bachelor's degree in a scientific discipline; 8+ years in pharmaceutical/biotech industry with at least 6 years in labeling or regulatory roles; deep knowledge of US and EU labeling requirements, regulations, and guidelines; experience with global regulatory submissions, including INDs, BLAs/NDA, MAAs, and structured product labels. HighValue: rare disease focus, global regulatory environment, experience with USPI and EU SmPC, involvement in development and post-marketing stages, and cross-functional collaboration with Clinical, Medical, Regulatory, and Quality teams. WorkSetup: remote in San Diego, with approximately 10% domestic and international travel.