Summary
(12 days per month on-site if living within 50 miles of our London office)
(Homebased if living further than 50 miles of our London office)
Internal job title: Global Program Regulatory Director (Neuroscience)
Office Location: Basel, Switzerland
We are seeking an accomplished Global Program Regulatory Director (GPRD) to lead regulatory strategy for high profile, innovative Neuroscience development programmes across the full product lifecycle. In this pivotal global role, you will define and drive regulatory strategy aligned with the Target Product Profile and broader portfolio, commercial, access, and exclusivity objectives. Acting as the regulatory leader on Global Program Teams, you will integrate inputs from Health Authorities, regional teams, and cross functional partners to identify opportunities, mitigate risk, and enable successful approvals and lifecycle optimisation.
About the Role
Major Accountabilities
Develop, document, and communicate robust global regulatory strategies for complex Neuroscience programmes, from early development through registration and lifecycle management.
Lead and manage Health Authority interactions, negotiations, and strategic engagements across major and emerging markets.
Identify regulatory opportunities and risks early, developing clear mitigation and contingency plans across regions.
Provide strategic regulatory input to development plans, labelling strategy, global promotional material, and key program decisions.
Lead execution of the global regulatory strategy, including submission planning, oversight of dossier content, critical review of submissions, and Health Authority responses.
Ensure full compliance with global regulatory requirements and adherence to internal regulatory policies and processes.
Support accelerated and complex submissions (e.g. MAA, BLA, NDA, new indications, variations, line extensions).
Provide matrix leadership to global reg