Global Regulatory Affairs Director (Neuroscience)
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description Summary
#LI-Hybrid (12 days per month on-site if living within 50 miles of our London office)#LI-Remote (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 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.
Job Description
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 subteams fostering alignment accountability and high performance.
Coach and mentor regulatory colleagues supporting capability building and career development.
Represent Regulatory Affairs on Global Program Teams crossfunctional initiatives and selected task forces.
Essential Requirements
Degree in a sciencebased discipline (BSc or MSc).
Demonstrated experience in global regulatory affairs and pharmaceutical development spanning early to latestage 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 problemsolving skills.
Commitment to Diversity and Inclusion / EEO paragraph
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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Required Experience:
Director
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
