VP, Global Regulatory Operations & Digital Transformation

Ipsen; Cambridge (MA); On-site; USD 250,000 - 380,000; Full time

Job summary

Ipsen Innovation (SAS) is seeking a Vice President, Head of Global Regulatory Operations to drive enterprise leadership across Regulatory Operations and enable Ipsen's global regulatory strategy. You will lead regulatory data, digital platforms, submissions and labelling governance to achieve excellence.

As a member of the Global Regulatory Affairs Leadership Team, you will partner with R&D, Quality, Medical, IT and Commercial to accelerate regulatory delivery and transform operations through AI

Qualifications

• Executive leadership experience within Research & Development in a global biopharmaceutical organization.
• Deep expertise across regulatory submissions, regulatory data, publishing, labelling, regulatory information management and digital technologies.
• Proven experience leading enterprise digital transformation, automation and AI-enabled initiatives.
• Strong executive stakeholder management with demonstrated ability to influence senior leaders across R&D, Quality, Medical, Commercial and Digital.

Responsibilities

• Define the Global Regulatory Operations strategy, operating model and long-term capability roadmap.
• Lead the transformation of Regulatory Operations through digital innovation, AI, automation and data-driven decision making.
• Build a high-performing global organization delivering inspection readiness and sustainable performance.
• Provide enterprise governance for regulatory systems, data, submission management and labelling.

Skills

Executive leadership

Regulatory operations

Regulatory submissions

Digital transformation

AI & automation in RA

Stakeholder management

Education

Bachelor’s degree

MBA or executive training

Advanced degree preferred

Job description

Ipsen Innovation (SAS) is seeking a Vice President, Head of Global Regulatory Operations to drive enterprise leadership across Regulatory Operations and enable Ipsen's global regulatory strategy. You will lead regulatory data, digital platforms, submissions and labelling governance to achieve excellence.

As a member of the Global Regulatory Affairs Leadership Team, you will partner with R&D, Quality, Medical, IT and Commercial to accelerate regulatory delivery and transform operations through AI