Vice President, Head of Global Regulatory Operations

Overview

As Head of Global Regulatory Operations, you will lead the enterprise-wide Regulatory Operations strategy to enable Ipsen’s global regulatory ambitions. You will partner with R&D, Quality, Medical, IT and Commercial to drive transformation through digitalization, AI and data-driven decision making. You’ll build a high-performing, globally dispersed team delivering regulatory data governance, submissions, labeling governance and platform excellence. This role shapes Ipsen’s regulatory execution and competitive edge while ensuring inspection readiness and sustainable performance. This is a strategic, cross-functional leadership opportunity with a strong impact on patients and company growth.

Responsibilities

• Define the strategic direction and operating model for Global Regulatory Operations aligned with GRA and R&D
• Lead a global leadership team and foster an inclusive, high-performing culture
• Represent Regulatory Operations in executive governance and influence enterprise decisions
• Oversee regulatory data governance, publishing, submissions, labeling, and regulatory systems
• Establish KPIs, dashboards and governance for quality, compliance and customer experience
• Ensure inspection readiness and ongoing regulatory compliance
• Define and execute digital transformation leveraging AI, automation and content management
• Lead labeling governance (CCDS, USPI, SmPC) and implement digital tools for lifecycle management
• Provide strategic oversight for major submissions and milestones with dashboards and predictive analytics
• Support submission excellence processes, project management and agile delivery
• Ensure compliance with global standards and laws; manage governance across the operation
• Sponsors business process harmonization and continuous improvement across the regulatory value chain
• Build external partnerships with authorities, industry, vendors to drive innovation
• Own the budget, vendor strategy and investment roadmap for Regulatory Operations
• Lead enterprise governance for regulatory operations and risk management

Key requirements

• Executive leadership in a global biopharma R&D setting
• Proven global operational strategy development and execution
• Experience leading large, geographically dispersed teams through transformation
• Deep expertise in regulatory submissions, data, publishing, labeling and regulatory information management
• Strong executive stakeholder management across R&D, Quality, Medical, Commercial and Digital
• Track record of leading enterprise digital transformation, automation and AI initiatives
• Experience managing significant budgets and outsourced partnerships
• Ability to build inclusive, high-performing teams and develop future leaders

• collaboration
• accountability
• innovation
• regulatory submissions
• regulatory data governance
• publishing

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