Global Program Regulatory Manager - Neuroscience

Novartis seeks a Global Program Regulatory Manager in Basel to drive regulatory strategies for neuroscience innovations, ensuring timely approvals and compliance across assigned regions.

This position is central to accelerating the delivery of neuroscience treatments to patients by overseeing regulatory execution. The manager leads the development and implementation of regulatory strategies for specific regions, ensuring high-quality submissions and effective engagement with Health Authorities. By translating complex clinical data into actionable regulatory deliverables, the role supports timely approvals and maintains strict compliance throughout the product lifecycle.

Responsibilities

• Execute regulatory strategies and manage day-to-day operational tasks for designated regions.
• Contribute to global regulatory planning by identifying potential risks or gaps in assigned areas.
• Collaborate with regional teams to synchronize regulatory plans and ensure smooth execution.
• Lead preparations for interactions with Health Authorities, including drafting briefing documents and response strategies.
• Coordinate the assembly and submission of regulatory dossiers across multiple regions.
• Review, approve, and submit Clinical Trial Applications and Investigational New Drug applications.
• Handle responses to Health Authority queries to facilitate timely approvals and reduce delays.

Requirements

• Proven experience in regulatory affairs within the pharmaceutical or biotechnology sectors.
• Solid understanding of regulatory submission processes and compliance standards.
• Background in supporting regulatory strategy and execution across diverse regions.
• Strong project management and organizational abilities, particularly in matrix environments.
• Capacity to work effectively with cross-functional teams and external stakeholders.
• Excellent problem-solving skills and meticulous attention to detail in regulatory decisions.
• Clear communication skills with the ability to interpret and present technical information effectively.

About the company

Novartis fosters an inclusive work environment with diverse teams that reflect the patients and communities it serves. The company culture is built on a community of smart, passionate individuals who collaborate, support, and inspire each other to achieve breakthroughs that change patients’ lives.

• Commitment to building an outstanding, inclusive work environment.
• Diverse teams representative of patients and communities.
• Community of smart, passionate people collaborating to achieve breakthroughs.