Global Regulatory Affairs Manager (Early Development)

Novartis; City Of London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking an experienced Global Program Regulatory Manager in London. This critical role entails managing regulatory strategy and operational activities, ensuring compliance with global requirements for pharmaceutical products. The ideal candidate will have a strong background in regulatory affairs, with a focus on timely submissions and collaboration across teams. This position offers a hybrid work model with a commitment to diversity and inclusion.

Qualifications

• 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.

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.
• Coordinate timely regulatory submissions across assigned regions.
• Review and approve Clinical Trial Applications (CTAs) and Risk Management Plans.
• Act as a liaison with local HAs.
• Ensure timely responses to HA queries and requests.
• Collaborate to align regulatory plans with business goals.
• Monitor compliance with internal policies and external regulations.
• Support or lead negotiations for regional approvals.

Skills

Clinical Trials

Detail-Oriented

Drug Development

Lifesciences

Negotiation Skills

Regulatory Compliance

Education

Bachelor's or Master's degree in Life Sciences or Pharmacy

Job description

Job Description Summary

#LI-Hybrid (12 days per month on-site)

Location: London (The Westworks), United Kingdom

Internal Job Title: Global Program Regulatory Manager

Job Description

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.

Major Accountabilities

• 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.

Skills Desired

• Clinical Trials
• Detail-Oriented
• Drug Development
• Lifesciences
• Negotiation Skills
• Regulatory Compliance