Vice President, Head of Global Regulatory Operations

Title:

Vice President, Head of Global Regulatory Operations

Company:

Ipsen Innovation (SAS)

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:

The Vice President, 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, en