Sr. Scientist-Global Labeling Lead

Role:
Senior Scientist, Global Labeling Lead, responsible for developing and maintaining compliant labeling content for development and marketed biopharma products, including Core, US, and EU Labeling. Objectives: ensure high-quality, regulatory-compliant labeling documents to support safe product use globally.

• lead cross-functional teams to create, review, and approve labeling;
• provide labeling expertise and strategic guidance;
• serve as the regulatory labeling contact for global submissions;
• develop labeling strategies and language for regulatory authorities.

• Bachelor's in a scientific or medical field;
• at least 3 years of relevant labeling or pharmaceutical industry experience, with experience leading cross-functional teams;
• strong understanding of regulatory labeling standards and scientific concepts;
• project management and communication skills.

• advanced degree (M.S., Pharm.D., Ph.D.),
• experience with regulatory submissions and global labeling standards.

• focus on biopharmaceutical products in development or marketed, with a global regulatory scope, supporting regulatory submissions in US and Europe.

• hybrid; travel approximately 10%.