Global Program Regulatory Director (Neuroscience)
Location: Basel, Switzerland
Work Location: 12 days per month on-site if within 50 miles of London office; Home-based if further.
Overview
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.
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 regulatory sub‑teams, fostering alignment, accountability, and high performance.
* Coach and mentor regulatory colleagues, supporting capability building and career development.
* Represent Regulatory Affairs on Global Program Teams, cross‑functional initiatives, and selected task forces.
Essential Requirements
* Degree in a science‑based discipline (BSc or MSc).
* Demonstrated experience in global regulatory affairs and pharmaceutical development, spanning early‑ to late‑stage programmes.
* Proven capability in leading complex global regulatory strategies, ideally within Neuroscience and innovative or rare disease areas.
* Strong experience with major global submissions, including registration, accelerated pathways, and significant lifecycle variations.
* Deep understanding of Health Authority engagement, regulatory guidance interpretation, and strategic negotiations.
* Track record of operating as a core member of Global Program Teams, influencing development, approval, and lifecycle strategy.
* Excellent communication, influencing, and problem‑solving skills.
Commitment to Diversity and Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e‑mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Benefits and Rewards
Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
#J-18808-Ljbffr