Director, Global Labelling Strategy & USPI Transformation

Ipsen Biopharmaceuticals Inc.; Greater London; On-site; GBP 120,000 - 180,000; Full time

Job summary

Ipsen Biopharm Ltd is seeking a Director, Regulatory Affairs, Labelling to lead the development and execution of global labelling strategies across early and late-stage development, lifecycle management, and marketed portfolios. You will ensure alignment with asset strategy and maximise future labelling opportunities on a global scale.

You will partner with Regulatory Affairs, Medical Affairs, Safety, Clinical Development and Commercial teams to influence strategy, evidence generation and label

Responsibilities

• Global Labelling Strategic Leadership: Define and drive the development of global labelling content strategies aligned with the asset strategy, regulatory requirements, labelling guidelines and Ipsen processes.
• Proactively develop labelling proposals and recommendations, lead cross-functional alignment and secure timely decisions through governance bodies.
• Lead the development and maintenance of core and major markets labelling (CCDS, USPI and EU PI), facilitating review and endorsement through the Labelling Team and Executive Labelling Committee, ensuring compliance, consistency and high-quality labelling outcomes throughout the product lifecycle.
• Act as Therapeutic Area (TA) Lead, providing strategic leadership and oversight across all products within the assigned TA, ensuring consistency of labelling strategy, scientific positions, key messaging, and regulatory approaches across development and marketed assets.
• Provide strategic guidance, coaching and functional leadership to Global Labelling professionals responsible for products within the TA, ensuring alignment with TA priorities, regulatory trends and business objectives.
• Contribute to the development of the Target Product Label by defining key labelling product claims in early development programs, identifying labelling-relevant clinical endpoints, providing strategic input into the design of Phase 2 and Phase 3 clinical trials and assessing the integration of patient data (e.g. PRO, QoL...).
• Contribute to regulatory agency interactions and negotiations involving labelling content; address inconsistencies in global labelling implementation or compliance.
• Global Labelling Capability Building and USPI Transformation: Coach, mentor and develop the Global labelling professionals

Job description

Ipsen Biopharm Ltd is seeking a Director, Regulatory Affairs, Labelling to lead the development and execution of global labelling strategies across early and late-stage development, lifecycle management, and marketed portfolios. You will ensure alignment with asset strategy and maximise future labelling opportunities on a global scale.

You will partner with Regulatory Affairs, Medical Affairs, Safety, Clinical Development and Commercial teams to influence strategy, evidence generation and label