Global Regulatory Operations Leader: Strategy & Digital

Ipsen; Paris; Sur place; EUR 180 000 - 300 000; Plein temps

Résumé du poste

Ipsen seeks a visionary Head of Global Regulatory Operations to lead enterprise-wide strategy, governance and transformation across Regulatory Affairs. You will drive regulatory data platforms, submissions, labeling governance and performance, partnering with R&D, Quality, Medical, IT and Commercial to accelerate delivery.

The role requires executive leadership, deep regulatory knowledge, and a track record of delivering global programs through digitalization and continuous improvement to ensure

Qualifications

• Executive leadership experience within a global biopharmaceutical organization.
• Proven track record delivering global regulatory programs and transformations.
• Experience in regulatory data governance, submissions and labeling governance.

Responsabilités

• Define the strategic direction and operating model for Global Regulatory Operations aligned with R&D objectives.
• Lead digital transformation initiatives for regulatory data, AI and automation.
• Ensure inspection readiness and sustainable regulatory compliance across regions.
• Provide governance for regulatory systems, data, submissions and labeling.
• Drive cross-functional collaboration with R&D, Quality, Medical, IT and Commercial.

Connaissances

Executive leadership

Regulatory operations

Global regulatory strategy

Digital transformation

AI & data-driven decisions

Stakeholder management

Budget management

Regulatory data governance

Formation

Bachelor’s degree

MBA or executive training

Outils

Regulatory tracking systems

EDMS

Publishing suites

Description du poste

Ipsen seeks a visionary Head of Global Regulatory Operations to lead enterprise-wide strategy, governance and transformation across Regulatory Affairs. You will drive regulatory data platforms, submissions, labeling governance and performance, partnering with R&D, Quality, Medical, IT and Commercial to accelerate delivery.

The role requires executive leadership, deep regulatory knowledge, and a track record of delivering global programs through digitalization and continuous improvement to ensure