Director, Regulatory Affairs, Labelling

Director, Regulatory Affairs, Labelling

Location: London (UK).

About the role

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, ensuring 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 support the safe and effective use of Ipsen products. Accountable for the quality and consistency of labelling content ...