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- Tasks: Lead regulatory submissions and ensure compliance for global clinical trials.
- Company: Join The George Institute for Global Health, dedicated to improving global health through innovative research.
- Benefits: Enjoy a competitive salary, dynamic work environment, and the chance to make a global impact.
- Why this job: Be part of a creative team shaping the future of clinical trials with cutting-edge methodologies.
- Qualifications: Experience in clinical trial regulatory affairs and strong communication skills are essential.
- Other info: This role is based in London and offers a fixed-term contract of 2-3 years.
The predicted salary is between 44000 - 66000 £ per year.
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 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 PersonWe’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.
Regulatory Affairs Manager - Clinical Trials employer: The George Institute for Global Health
Contact Detail:
The George Institute for Global Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager - Clinical Trials
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks relevant to clinical trials in the UK, Europe, Australia, and India. Understanding the nuances of each region's regulations will not only boost your confidence but also demonstrate your expertise during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with global clinical trials. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory compliance.
✨Tip Number 3
Stay updated on the latest ICH-GCP guidelines and any changes in global regulatory policies. Being knowledgeable about current developments will help you stand out as a candidate who is proactive and well-informed.
✨Tip Number 4
Prepare to discuss your experience with leading regulatory submissions and managing compliance challenges in previous roles. Use specific examples to illustrate your problem-solving skills and ability to work with diverse teams in dynamic environments.
We think you need these skills to ace Regulatory Affairs Manager - Clinical Trials
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Affairs Manager position. Familiarise yourself with clinical trial regulations and the specific challenges mentioned in the job description.
Tailor Your CV: Highlight your relevant experience in regulatory affairs, particularly in clinical trials. Emphasise your knowledge of global regulations and any specific achievements that demonstrate your ability to navigate complex compliance landscapes.
Craft a Compelling Cover Letter: Use your cover letter to showcase your passion for regulatory affairs and your understanding of the innovative work at The George Institute. Mention specific experiences that align with the key responsibilities outlined in the job description.
Showcase Your Skills: In your application, clearly demonstrate your problem-solving abilities, communication skills, and experience in training teams on compliance measures. Provide examples of how you've successfully managed regulatory submissions in the past.
How to prepare for a job interview at The George Institute for Global Health
✨Know Your Regulations
Familiarise yourself with the latest global clinical trial regulations, especially those relevant to the UK, Europe, Australia, and India. Be prepared to discuss how you have navigated these regulations in past roles and how you can apply this knowledge to the position.
✨Showcase Your Experience
Highlight your previous experience in leading regulatory submissions for clinical trials. Use specific examples to demonstrate your ability to guide research teams through compliance challenges and your success in fostering relationships with regulatory authorities.
✨Communicate Clearly
Practice articulating complex regulatory requirements in a clear and concise manner. During the interview, focus on how you can simplify intricate information for diverse stakeholders, showcasing your communication skills.
✨Demonstrate Problem-Solving Skills
Be ready to discuss instances where you've assessed regulatory risks and proposed practical solutions. This will show your proactive approach and ability to think critically in dynamic research environments.
