Salary Range:

CHF93,800.00 - CHF174,200.00

Band

Level 4

Job Description Summary

Work Arrangement: Hybrid, #LI-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
Drive regulatory execution that enables innovation in neuroscience to reach patients faster. As Regulatory Affairs Manager – Neuroscience, you will play a key role in delivering regulatory strategies across assigned regions, ensuring high-quality submissions and effective interactions with Health Authorities. Working cross-functionally, you will translate complex scientific and clinical data into regulatory deliverables, supporting timely approvals and maintaining compliance throughout the product lifecycle. This role offers the opportunity to build deep regulatory expertise while contributing to impactful global programs in a dynamic and collaborative environment.

Job Description

Key Responsibilities

Implement regulatory strategy and manage operational activities across assigned regions
Support development of global regulatory strategy and identify risks or gaps for assigned regions
Partner with regional teams to align regulatory plans and ensure effective execution
Lead preparation of Health Authority interactions, including briefing documents and response plans
Drive 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 minimising 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 organisational skills in a matrix environment
Ability to collaborate with cross-functional teams and external stakeholders
Strong problem-solving skills and attention to detail in regulatory decision-making
Effective communication skills and ability to interpret and present technical information clearly

Commitment to Diversity and Inclusion

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 to receive more detailed information about the essential functions of a position, please email 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 takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Skills Desired

Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

Global Program Regulatory Manager - Neuroscience