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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.
About the Role
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)
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)
