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:

Job Title:

Director, Regulatory Affairs, Labelling

Division / Function:

Global Regulatory Affairs, Regulatory Operations

WHAT - 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 “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 across global markets, and actively contributes to interactions with regulatory authorities during labelling development and negotiation.
• Play a key role in driving transformation, process excellence, and capability building across Global Labelling by providing clear direction and ensuring high-quality and timely delivery of labelling outputs .

WHAT - Main Responsibilities & Technical Competencies

Strategic leadership of global labelling:

• Drive the development of global labelling strategies in alignment with the overall asset strategy and processes.
• Contribute to early development programs by identifying labeling-relevant clinical endpoints, provide strategic input into the design of Phase 2 and Phase 3 clinical trials, and contribute to the definition of the key product claims and the development of Target Product Profile.
• Develop and maintain core labelling documents and major market labels (e.g. CCDS, USPI, EU SmPC/PIL); manages and facilitates review of CCDSs and regional labelling via the Labelling Team and Executive Labelling Committee. Secures appropriate approvals on labelling decisions.
• Accountable for proposing and driving labelling positions, leading cross-functional alignment, and escalating key issues to governance committees to secure decisions.
• Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions.

End-to-end ownership of core labelling deliverables with strong USPI oversight:

• Lead cross functionally the development and lifecycle management of CCDS, USPI and EU PI (SmPC/PIL) for assigned products.
• Mentor and guide the team to strengthen strategic and technical labelling expertise, including providing strategic oversight of USPI development and ensuring alignment with global labelling strategy and US regulatory requirements. Establish and continuously evolve best practices to deliver high-quality, consistent, and efficient global labelling across products and regions.
• Lead or contribute to strategic transformation initiatives, including labelling process standardization, digitalisation, and structured content approaches, to enhance efficiency and consistency across global labelling activities.
• Monitor competitor intelligence, regulatory trends, and evolving guidance to inform labelling strategy; work with Regulatory Affairs strategist to research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory autho