Job Description Summary

#LI-Hybrid (3 days per week on-site)

Location: London (The Westworks), United Kingdom or Dublin, Ireland

Internal Job Title: Global Program Regulatory Manager

We are seeking an experienced and proactive Regulatory Affairs Manager to join our Global Regulatory Affairs team. This role is essential in shaping regulatory strategy and overseeing operational activities across key regions. You will work with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory standards, supporting the development and commercialization of pharmaceutical products.

Major Responsibilities:

1. Implement regional regulatory strategies aligned with global objectives.
2. Contribute to global regulatory planning, identifying strategic gaps or risks.
3. Lead or support interactions with Health Authorities (HAs), including preparing briefing materials.
4. Coordinate timely and compliant regulatory submissions across assigned regions.
5. Review and approve Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), and Risk Management Plans.
6. Act as liaison with local HAs (e.g., FDA, EMA) as required.
7. Ensure timely and effective responses to HA queries and requests.
8. Collaborate cross-functionally to align regulatory plans with business goals.
9. Monitor and ensure compliance with internal policies and external regulations.
10. Support or lead negotiations for regional approvals to meet project timelines.

Essential Requirements:

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

Commitment to Diversity and Inclusion/EEO

Novartis is dedicated to building an inclusive and diverse work environment that reflects the communities we serve.

Why Novartis:

Helping people with disease and their families requires more than science. It takes a community of passionate, innovative individuals like you. Join us in creating breakthroughs that change lives.

Learn more about our culture

Join our Novartis Network:

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Benefits and Rewards:

Discover how we support your growth at https://www.novartis.com/careers/benefits-rewards

Skills Desired