Director, Regulatory Affairs, Labelling

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 endeavour 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!

Job Description:

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.

Main Responsibilities & Technical Competencies:

• 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.
• Secure appropriate approvals on labelling decisions.
• Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions.
• 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.
• Establish and continuously evolve best practices to deliver high-quality, consistent, and efficient global labelling across products and regions.
• Monitor competitor intelligence, regulatory trends, and evolving guidance to inform labelling strategy.
• Provide oversight to Global, Regional, and Local Regulatory personnel and external partners involved in the development or management of labelling content.

Behavioural Competencies Required:

• Define and drive a clear global labelling strategy aligned with asset development and lifecycle objectives.
• Integrate complex and sometimes conflicting inputs into robust labelling decisions.
• Drive alignment and decision-making across cross-functional and matrix teams without direct authority.
• Build strong partnerships across Global, Regional, and Local Regulatory teams.
• Engage, guide, and develop team members and stakeholders to deliver high-quality labelling outcomes.

Knowledge & Experience (essential):

• Strong knowledge of global regulatory labelling requirements (FDA, EMA, ICH) and lifecycle labelling best practices.
• Demonstrated expertise in the development and maintenance of core labelling (CCDS) and major market labels, including USPI and EU SmPC/PIL.
• Proven ability to define and implement global labelling strategies.
• Strong scientific and analytical capability to interpret complex data and translate it into clear, compliant, and strategically sound labelling content.
• Strong project management skills, with the ability to manage multiple priorities and ensure high-quality and timely delivery of labelling deliverables.

Education / Certifications (essential):

• Advanced degree in life sciences, pharmacy, medicine or related field.
• Significant experience in regulatory affairs within the pharmaceutical or biotechnology industry.