Major Responsibilities:

• Implement regional regulatory strategies in alignment with global objectives.
• Contribute to global regulatory planning and identify strategic gaps or risks.
• Lead or support Health Authority (HA) interactions, including briefing material preparation.
• Coordinate timely and compliant regulatory submissions across assigned regions.
• Review and approve Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), and Risk Management Plans.
• Act as a liaison with local HAs (e.g. FDA, EMA) as required.
• Ensure timely and effective responses to HA queries and requests.
• Collaborate cross-functionally to align regulatory plans with business goals.
• Monitor and ensure compliance with internal policies and external regulations.
• Support or lead negotiations for regional approvals to meet project timelines.

Essential Requirements:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
• Proven experience in regulatory affairs within the pharmaceutical industry.
• Strong understanding of drug development and clinical trial processes.
• Experience in managing regulatory submissions and HA interactions.

Commitment to Diversity and Inclusion/EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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

Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards