Global Program Regulatory Manager / Global Program Regulatory Manageress

Job ID

REQ-10080339

Jun 16, 2026

Switzerland

Summary

#Li-Hybrid
Work Arrangement: Hybrid
Location: Basel, Switzerland
Relocation Support: This role is based in Basel, Switzerland. Novartis is unable to offer relocation support; please only apply if accessible.

About the Role

As the Regulatory Affairs Manager in Neuroscience, you will play a crucial role in driving regulatory execution that fosters innovation to reach patients faster. You will be responsible for developing regulatory strategies across assigned regions, ensuring high-quality submissions, and facilitating effective interactions with Health Authorities. This position involves collaborating with cross-functional teams to translate intricate scientific and clinical data into regulatory deliverables, supporting timely approvals and maintaining compliance throughout the product lifecycle. This role presents an opportunity to build profound regulatory expertise while contributing to impactful global programs in a dynamic and collaborative environment.

Key Responsibilities

• Implement regulatory strategy and manage operational activities across assigned regions.
• Assist in the development of global regulatory strategies while identifying risks or gaps for assigned regions.
• Collaborate with regional teams to align on regulatory plans and ensure effective execution.
• Lead the preparation for Health Authority interactions, including briefing documents and response plans.
• Drive the coordination and submission of regulatory dossiers across assigned regions.
• Review, approve, and submit Clinical Trial Applications and Investigational New Drug applications.
• Manage responses to Health Authority queries and support timely approvals while minimizing delays.

Essential Requirements

• Experience in regulatory affairs within pharmaceutical or biotechnology environments.
• Knowledge of regulatory submission processes and compliance requirements.
• Experience supporting regulatory strategy and execution across multiple regions.
• Strong project management and organizational skills in a matrix environment.
• Ability to collaborate effectively with cross-functional teams and external stakeholders.
• Strong problem-solving skills and meticulous attention to detail in regulatory decision-making.
• Effective communication skills and the ability to interpret and present technical information clearly.

Commitment to Diversity and Inclusion

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

Accessibility and Accommodation

Novartis is committed to working with and providing reasonable accommodations to all individuals. If, due to a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please reach out to inclusion.switzerland@novartis.com and share the nature of your request along with your contact information. Please include the job requisition number in your message.

Why Novartis

Helping people with disease and their families takes more than innovative science. It requires a community of dedicated, passionate individuals collaborating, supporting, and inspiring one another. Together, we aim to achieve breakthroughs that truly change patients' lives. Are you ready to join us in creating a brighter future?

Benefits and Rewards

Discover all the ways we can support you in thriving both personally and professionally.

For application details, apply online using the form below.

Note: Only applications matching the job profile will be considered.

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