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Regulatory Affairs Manager – Clinical TrialsLondon | Fixed-Term (2–3 Years) | £52,000–£60,000 | Full-time
The Role
Are you confident navigating complex global clinical trial regulations? Do you bring experience guiding research teams through the challenges of compliance in an evolving regulatory landscape and leading clinical trial submissions for CTIMPs and/or medical devices?
We’re looking for an experienced Regulatory Affairs Manager to join our new Innovative Trials Hub at The George Institute for Global Health. Based in London, this pivotal role supports cutting-edge clinical trials across global settings—ensuring compliance, clarity, and confidence from design to delivery.
Reporting to the Director of Global Project Operations and working alongside the Hub team of experts in operations, data science and methodology, you will provide strategic and practical regulatory advice to international teams designing platform, adaptive and decentralised trials. You will also collaborate closely with key global regulatory authorities and research partners such as Imperial Clinical Trials Unit & University of New South Wales Clinical Research Unit.
Ready to make a global impact in regulatory innovation? Apply now to join a creative, forward-thinking and innovative team shaping the future of clinical trials.
Key Responsibilities:
- Lead the preparation and submission of regulatory documents across global agencies (e.g. MHRA, FDA, EMA, CDSCO, TGA).
- Offer clear advice on trial compliance requirements and novel design pathways.
- Stay ahead of updates to ICH-GCP guidelines, and global regulatory shifts.
- Act as key contact with regulatory authorities, fostering strong relationships.
- Develop and maintain internal processes for efficient, compliant submissions.
- Assess regulatory risks in trial delivery and propose practical solutions.
- Train and support project teams on policy changes and compliance measures.
The Company
The George Institute for Global Health was established in 1999 with a mission to improve the health of millions of people worldwide, especially those in underserved populations, by challenging the status quo and using innovative approaches to prevent and treat the world’s biggest killers: non-communicable diseases and injury.
With offices in the United Kingdom (UK), Australia, and India, our 700+ staff members support 245+ active projects and clinical trials over 50 countries. We focus on the global health challenges that cause the greatest loss of life, the greatest impairment of life quality and the most substantial economic burden, particularly in resource-poor settings.
The Innovative Trials Hub was established at TGI in 2024 with the mission for TGI to become a global leader and an international reference for large-scale, ambitious and patient-centric trials through innovative design, methodology, conduct, operations and publication.
The Person
We’re looking for someone who can:
- Demonstrate solid knowledge & experience in clinical trial regulatory affairs across UK, Europe, Australia, India and other global jurisdictions
- Confidently interpret and apply evolving regulations in trials using drugs, devices, or data
- Communicate complex requirements clearly and concisely
- Work independently and advise senior stakeholders
- Thrive in dynamic, international research settings
- Bring strong documentation, problem-solving, and relationship-building skills
- Knowledge of decentralised or adaptive trial designs is highly desirable.
