Job Details
Regulatory Affairs Manager
- £Competitive
- London, Greater London, United Kingdom
- Permanent
Regulatory Affairs Manager
Location: London (Hybrid)
Are you a regulatory expert with a sharp eye for detail and a passion for facilitating access to critical medicines across the globe? An established and fast-growing healthcare organisation is seeking a Regulatory Affairs Manager to drive global regulatory strategy and execution across a diverse portfolio of access programs and clinical projects.
Why This Role?
This is not your average regulatory position. You’ll be working across a broad spectrum of regulatory pathways - from Expanded Access Programs (EAPs) and Named Patient Programs to Compassionate Use and Clinical Trials. Your insights and leadership will help ensure patients with urgent unmet medical needs can access the treatments they need, in compliance with complex international regulations.
What You’ll Be Doing
- Act as the primary regulatory contact for multiple global access and clinical trial projects.
- Develop regulatory strategies that enable compliant, timely patient access to products in markets across the US, Europe, and beyond.
- Lead the preparation and submission of regulatory applications to agencies such as the MHRA, ANSM, FDA, and others.
- Provide site-level regulatory support and help stakeholders navigate country-specific requirements.
- Monitor and manage regulatory documentation and changes, ensuring clear communication with internal teams.
- Engage in client meetings, proposals, and bid defences to provide regulatory input on program design and execution.
- Collaborate closely with Quality, Medical Affairs, Supply Chain, and Project Management teams to ensure cohesive project delivery.
- Maintain regulatory licenses in select jurisdictions (US, UK, Ireland) and manage variations with health authorities as needed.
- Mentor or oversee junior regulatory staff, supporting their development and contributing to continuous process improvement.
What You’ll Bring
- A Bachelor’s degree (life sciences, legal, or related field preferred).
- 3+ years’ experience in global regulatory affairs, ideally across clinical trials or unlicensed medicine access programs.
- Familiarity with EU and FDA regulations and strong practical knowledge of submission processes.
- Experience creating and executing regulatory strategies in cross-functional environments.
- Confidence in managing health authority interactions and responding to regulatory queries.
- Strong analytical and communication skills. Able to translate regulations into practical, project-ready advice.
- Highly organised, proactive, and comfortable balancing multiple priorities in a fast-paced setting.
What’s in It for You?
- A unique opportunity to work across diverse regulatory frameworks with real patient impact.
- A collaborative, flexible environment where regulatory expertise is truly valued.
- The chance to be part of a purpose-driven organisation focused on accelerating access to critical treatments.
Interested? Apply now or send your CV to megan@warmanobrien.com.
