Director, Regulatory Affairs, Labelling

Ipsen; England; On-site; GBP 120,000 - 180,000; Full time

Job summary

Ipsen is seeking a Director of Regulatory Affairs, Labelling to lead the global labelling strategy for assigned products across development, lifecycle management and marketed portfolios. You will shape labelling strategy early in development by providing regulatory input into clinical development plans, ensuring alignment between clinical evidence and labeling opportunities.

This role requires cross-functional collaboration with clinical, medical, regulatory operations and commercial teams to

Responsibilities

• Lead global labelling strategy development and implementation across products.
• Provide regulatory input into clinical development plans to align evidence with labeling opportunities.
• Coordinate labeling changes, safety narratives and pack copy with global regulatory teams.

Job description

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