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 Governance:

• Establish enterprise governance for regulatory operations, ensuring clear decision-making, accountability, risk management and cross-functional alignment.
• Sponsor business process harmonization and continuous improvement initiatives across the regulatory value chain.

External Leadership:

• Build strategic partnerships with Health Authorities, industry associations, technology vendors and external partners to position Ipsen at the forefront of Regulatory Operations innovation.

Financial & Resource Management:

• Own the Global Regulatory Operations budget, vendor strategy and investment roadmap.
• Optimize organizational resources and external partnerships to deliver sustainable operational performance.

Knowledge & Experience

Knowledge & Experience (essential):

• Executive leadership experience within Research & Development in a complex, global biopharmaceutical organization.
• Proven experience developing and executing global operational strategies that support business growth and regulatory excellence.
• Demonstrated leadership of large global, geographically dispersed organisations through significant transformation and organisational change.
• Deep expertise across regulatory submissions, regulatory data, publishing, labelling, regulatory information management and digital technologies.
• Strong executive stakeholder management with demonstrated ability to influence senior leaders across R&D, Quality, Medical, Commercial and Digital.
• Proven experience leading enterprise digital transformation, automation and AI-enabled initiatives.
• Experience managing significant operational budgets, strategic vendors and outsourced partnerships.
• Demonstrated ability to build inclusive, high-performing organisations and develop future leadership capability.

Knowledge & Experience (preferred):

• At least 10 years’ experience managing a worldwide Regulatory team
• At least 15 years’ experience in Pharmaceutical Industry (R&D or Pharmacovigilance), 5 years’ experience working in regulatory affairs, experience in managing complex regulatory submissions
• Experience in Regulatory Tools Administration (mainly regulatory tracking database and EDMS)
• High level knowledge in IT tools used for electronic dossier management and publishing: electronic document management systems, publishing suites, regulatory tracking systems
• Experience in the Data management methodology implementation and Data integrity principles
• Experience in the management of regulatory data and the Regulatory Data Governance to ensure availability, usability, integrity and security of high-quality data for RA community
• Key business analyst skills
• Fluent with the review regulatory processes
• Demonstrable experience of leading successful engagement with key regulatory authorities
• Proven track record in building and leading teams of skilled regulatory professionals to deliver business

Education / Certifications (essential):

• Bachelor’s degree
• Evidence of management/leadership education (MBA or executive training)

Education / Certifications (preferred):

• Advanced degree preferred
• Background in IT technologies or life sciences preferred

Language(s) (essential):

• Good oral and written communication skills
• Fluent English

Language(s) (preferred):

• Fluent French (preferred)

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. Soyons nous-même