Head of Global Regulatory Operations

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 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)