Director, Regulatory Affairs, Labelling

Job Title

Director, Regulatory Affairs, Labelling

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. Plays 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.

Ensures 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 support the safe and effective use of Ipsen products. Accountable for the quality...