Director, Regulatory Affairs, Labelling

Job Title: Director, Regulatory Affairs, Labelling
Division: Global Regulatory Affairs, Regulatory Operations

Summary & Purpose of the Position

• Responsible for leading the development and implementation of global labelling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios.
• Play an active role in shaping labelling strategy early in product development by providing regulatory input into clinical development plans. This strategic input ensures alignment between clinical evidence generation and future labeling opportunities aligned with the “CCDS as a driver” philosophy.
• Ensure that core labelling (e.g., Company Core Data Sheets) and major market labelling, with a strong focus on US Prescribing Information (USPI) alongside EU product information, comply with global regulatory requirements, reflect current scientific and clinical evidence, and sup...