Summary

About the Role

Major accountabilities:

• Create high-quality global regulatory strategies and manage Health Authority interactions to achieve development and business objectives.
• Identify and communicate potential regulatory opportunities and risks, and develop mitigation strategies.
• Utilize regional expertise to define and execute global regulatory strategies and engage with Health Authorities.
• Offer strategic regulatory input on key development, labeling, and promotional documents.
• Oversee submission planning, guide contributing authors, and critically review submission documentation.
• Lead interactions with regulatory and development management and external consultants for strategic input.
• Provide strategic regulatory and development input into Business Development & Licensing due diligence evaluations.
• Maintain compliance with global regulatory requirements and internal policies, and coordinate regulatory compliance activities.
• Lead regulatory teams, provide feedback and coaching, and support the growth and development of subteam members.
• Manage regulatory submissions, portfolio transformation activities, and business and operational excellence tasks.

Minimum requirements:

• Bachelor's or Master's in a science-based field; advanced degrees preferred.
• Fluent in English; additional languages are a plus.
• Significant experience in regulatory and pharmaceutical development (Phases I-IV).
• Expertise in regulatory strategy, scientific data analysis, and HA guidance.
• Significant experience with major submissions.
• Knowledge of post-marketing strategies and commercial awareness.
• Proven regulatory operations and compliance skills.
• Strong leadership and matrix management abilities.
• Excellent communication, influencing, and problem-solving skills.
• Ability to navigate organizational complexity effectively.

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

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