Senior EU Regulatory Lead – GI&I / Director

About the role

The Senior EU Regulatory Lead GI&I will define and drive regional regulatory strategies to ensure timely approval of investigational and market applications, supporting patient access across the EU.

Key responsibilities

• Develop and lead progressive regulatory strategies aligned with product development plans.
• Manage and execute regional regulatory submissions, ensuring timely approvals throughout product lifecycle.
• Lead the Submission Working Group and represent the region on global project teams.
• Interact with health authorities, including HTA bodies, to support value and access discussions.
• Provide tactical advice on development and lifecycle management of assigned products.

Required profile

• Minimum 10 years of drug regulatory affairs experience, preferably in the EU/GEM region.
• Experience with advanced therapeutic products such as cell and gene therapy.
• Proven ability to lead cross‑functional teams and mentor junior staff.
• Strong communication skills with health authorities and internal stakeholders.

Required skills

• EU regulatory submission processes and guidelines.
• Health authority interaction and negotiation.
• Regulatory strategy development for market access and lifecycle management.
• Knowledge of HTA processes and evidence requirements.