Director, Regulatory Affairs, Labelling

Title: Director, Regulatory Affairs, Labelling Company: Ipsen Biopharm Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram . Job Description: Director, Regulatory Affairs, Labelling WHAT - Summary & Purpose of the Position Lead the development and implementation of global labelling strategy for assigned products, across early and late-stage development, life cycle management (LCM), and marketed portfolios, ensuring alignment with asset strategy and maximizing future labelling opportunities. Serve as Global Labelling Therapeutic Area (TA) Lead for the assigned therapeutic area, providing strategic oversight across the portfolio, ensuring consistency of labelling approaches and key scientific positions, identifying portfolio-level risks and opportunities, and representing Global Labelling in cross-functional TA governance. Partner with senior leaders across Regulatory Affairs, Medical Affairs, Safety, Clinical Development and Commercial functions to influence product strategy, evidence generation and early label development. Contribute to clinical development plans and Target Product Label strategies to ensure alignment between clinical evidence generation and future labelling opportunities, consistent with the “CCDS as a driver” philosophy. Play a leading role in the transformation of Ipsen's future USPI operating model, including the progressive transition of USPI responsibilities into Global Labelling and the development of capabilities required for the future end-to end USPI ownership. Provide strategic oversight of 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, ensuring compliance with global regulatory requirements, current scientific and clinical evidence, and alignment across markets. Accountable for the quality, consistency and governance of labelling content globally, including interactions and negotiations with regulatory authorities supporting labelling development and approvals. Drive transformation, innovation and capability building across Global Labelling, including digitalisation, structured content approaches and AI-enabled solutions, while ensuring high-quality and timely delivery of labelling outputs . WHAT - Main Responsibilities & Technical Competencies 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, strengthening strategic and technical capabilities across the function. Play a leading role in the transformation of Ipsen’s future USPI operating model, supporting the transition of USPI responsibilities into Global Labelling and embedding new ways of working. Lead the development of the capabilities required for future end-to-end USPI ownership within Global Labelling and provide strategic oversight of USPI development to ensure alignment with global labelling strategy and US regulatory requirements. Lead or contribute to strategic transformation initiatives, including labelling process standardisation, digitalisation, and structured content approaches, to enhance efficiency, consistency and scalability across products and regions. Monitor competitor intelligence, regulatory trends, and evolving health authority expectations to inform labelling strategy, strengthen positioning and support regulatory negotiations. Collaborate with Regulatory Affairs Strategists to assess labels within the same therapeutic area, including competitor labelling, to inform labelling strategy, support the development of robust labelling positions and contingency approaches, and strengthen regulatory negotiation strategies. Provide strategic guidance and oversight to Global, Regional, and Local Regulatory teams and external partners involved in labelling activities, ensuring effective collaboration and consistent implementation of global labelling strategies. Ensure effective stakeholder engagement and communication across SMEs, Global Regulatory Leads, Compliance and other key functions, particularly for the implementation of safety-related labelling changes. Proactively identify, assess and escalate strategic labelling risks and opportunities to senior management and governance bodies. Innovation, Continu