Global Regulatory Affairs Director / Global Regulatory Affairs Directoress

Job ID

REQ-10076200

Date Posted

April 28, 2026

Location

Switzerland

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 looking for a highly qualified Global Program Regulatory Director (GPRD) to spearhead regulatory strategies for innovative Neuroscience development programs throughout the entire product lifecycle. In this crucial global role, you will define and execute regulatory strategies in alignment with the Target Product Profile, overarching portfolio objectives, commercial expectations, access considerations, and exclusivity goals. As the regulatory leader on Global Program Teams, you will integrate insights from Health Authorities, regional teams, and cross-functional partners to identify opportunities, mitigate risks, and facilitate successful approvals and lifecycle optimization.

About the Role

Major Accountabilities

• Develop, document, and communicate robust global regulatory strategies for complex Neuroscience programs, from early development through registration and lifecycle management.
• Lead and manage Health Authority interactions, negotiations, and strategic engagements across both major and emerging markets.
• Identify regulatory opportunities and risks early, crafting clear mitigation and contingency plans across regions.
• Provide strategic regulatory input to development plans, labeling strategies, global promotional materials, and key program decisions.
• Oversee the execution of the global regulatory strategy, including submission planning, content oversight, critical reviews of submissions, and Health Authority responses.
• Ensure full compliance with global regulatory requirements and 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, promoting alignment, accountability, and high performance.
• Coach and mentor regulatory colleagues to foster 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, encompassing early to late-stage programs.
• 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 contributing as a core member of Global Program Teams, influencing development, approval, and lifecycle strategy.
• Excellent communication, influencing, and problem-solving abilities.

Commitment to Diversity and Inclusion

Novartis is dedicated to cultivating an outstanding, inclusive work environment and diverse teams that reflect the patients and communities we serve.

Accessibility and Accommodation

Novartis is committed to collaborating with and providing reasonable accommodations to all individuals. If you need a reasonable accommodation for any part of the recruitment process due to a medical condition or disability, or if you wish to receive more information about the essential functions of a position, please reach out via email to inclusion.switzerland@novartis.com with your request and contact information. Be sure to include the job requisition number in your message.

Why Novartis?

Helping patients and their families manage disease requires more than innovative science; it necessitates a community of intelligent, passionate individuals like you. Together, we can collaborate, support, and inspire one another, ultimately achieving breakthroughs that enhance the lives of patients. Are you ready to create a brighter future together? Learn more about us.

Benefits and Rewards

Discover all the ways we can support your personal and professional growth. Read our handbook.

Division

Development

Business Unit

Development

Location

Switzerland

Site

Basel (City)

Company / Legal Entity

C028 (FCRS = CH028) Novartis Pharma AG

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Global Regulatory Affairs Director (Neuroscience)

Apply online using the form below. Only applications matching the job profile will be considered.