Head of Global Regulatory Operations

Titre : Head of Global Regulatory Operations Société: Ipsen Innovation (SAS)

A propos d'Ipsen: Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation. Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d’Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s’épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société. Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com

Description de l'emploi : The Head of Global Regulatory Operations provides enterprise leadership for Regulatory Operations across Global Regulatory Affairs (GRA), defining the long‑term vision, operating model and capabilities required to enable Ipsen's global regulatory strategy. The role is accountable for ensuring world‑class regulatory operations through excellence in regulatory data, digital platforms, submissions, labelling governance and operational execution. As a member of the Global Regulatory Affairs Leadership Team, the VP partners across R&D, Quality, Medical, IT and Commercial functions to drive enterprise transformation, accelerate regulatory delivery and strengthen Ipsen's competitive advantage through innovation, digitalization and operational excellence. The role is accountable for: Defining and executing the Global Regulatory Operations strategy aligned with Ipsen's corporate and R&D objectives. Leading the transformation of Regulatory Operations through digital innovation, AI, automation and data‑driven decision‑making. Building a high‑performing global organization that delivers operational excellence, inspection readiness and sustainable business performance. Providing enterprise governance for regulatory systems, regulatory data, submission management and global labelling. Driving a culture of collaboration, accountability, innovation and continuous improvement.

Main Responsibilities & Technical Competencies

Enterprise Leadership & Strategy

• Define the strategic direction, operating model and long‑term capability roadmap for Global Regulatory Operations, ensuring alignment with Global Regulatory Affairs, R&D strategy and future business priorities.
• Lead a global leadership team, building organizational capability, succession plans and an inclusive, high‑performing culture.
• Represent Regulatory Operations within executive governance forums and influence enterprise decision‑making.

Operational Excellence

• Own enterprise performance across Regulatory Operations including regulatory data governance, publishing, submissions, labelling, regulatory systems and operational delivery.
• Establish KPIs, governance and performance dashboards to continuously improve quality, compliance, productivity and customer experience.
• Ensure inspection readiness and sustainable compliance with evolving global regulatory requirements.

Digital Transformation

• Define and deliver the digital transformation strategy for Regulatory Operations, leveraging AI, automation, structured content management and emerging technologies to improve efficiency, scalability and regulatory effectiveness.
• Partner with Digital & IT to modernize platforms, strengthen data governance and develop future‑ready regulatory capabilities.

Labelling (CCDS, USPI and SmPC)

• Lead global labelling governance ensuring consistency and compliance; implement digital tools for labelling lifecycle management; explore AI‑driven solutions for signal detection and automated updates.

Regulatory Project Management

• Provide strategic oversight for major submissions and regulatory milestones develop project dashboards and predictive analytics for risk management champion agile methodologies for faster delivery under submission, excellence Own and improve Submission Excellence process & playbook, support IND Excellence project Compliance Support inspection readiness for audits of Global Regulatory Affairs Organizes and ensures compliance to global standards & laws applicable to Global Regulatory Affairs, ensuring all systems are in compliance with GRA requirements.

Enterprise Gov