Associate Director, Regulatory Labeling Strategy

Associate Director, Labeling Strategy, responsible for developing and executing global regulatory labeling strategies throughout the product lifecycle for rare disease therapies.

• Lead cross-functional Labeling Working Group
• Coordinate with Health Authorities
• Author and manage labeling documents (USPI, CCDS, TPL)
• Develop global labeling implementation plans
• 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

• 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

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.

Remote in San Diego, with approximately 10% domestic and international travel.