Global Regulatory Affairs Manager (Global Program Regulatory Manager)

Novartis Farmacéutica; London; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

A leading pharmaceutical company is seeking a Global Regulatory Affairs Manager to drive regulatory strategy and compliance for drug development. This role involves cross-functional collaboration, managing regulatory submissions and ensuring adherence to global regulatory requirements. Candidates should have a strong background in regulatory affairs, a relevant degree, and a commitment to fostering an inclusive workplace culture.

Qualifications

• Proven experience in regulatory affairs within the pharmaceutical industry.
• Strong understanding of drug development and clinical trial processes.
• Experience managing regulatory submissions and interactions with Health Authorities.

Responsibilities

• Implement regional regulatory strategies aligning with global objectives.
• Coordinate timely and compliant regulatory submissions across regions.
• Lead interactions with Health Authorities and ensure compliance.

Skills

Regulatory Affairs

Cross-Functional Collaboration

Compliance Monitoring

Strategic Planning

Education

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field

Job description

Global Regulatory Affairs Manager (Global Program Regulatory Manager)

Job ID REQ-10051589

United Kingdom

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 looking for an experienced and proactive Regulatory Affairs Manager to join our Global Regulatory Affairs team. This role is critical in driving regulatory strategy and managing operational activities across key regions. You will collaborate with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory requirements, supporting the successful development and commercialization of pharmaceutical products.

About the Role

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.
• 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

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

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Alternative Location 1 Dublin (NOCC), Ireland

Functional Area Research & Development

Job Type Full time

Employment Type Regular

Shift Work No

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