Regulatory Affairs Lead – Clinical Trials

Location: UK, Remote – Travel 2x per year (Must be based and living in the UK)

We’re partnered with a cutting-edge, oncology-focused organisation delivering early- and late-phase clinical trials on a global scale, now looking to appoint a Regulatory Affairs Leader to join their growing team.

This is a fantastic opportunity for an experienced Regulatory professional to take ownership of global clinical trial strategy, working in a highly collaborative, science-driven environment. Being the Regulatory Leader, you will line manage a small team of two professionals and MUST have prior experience in leadership. The role is fully remote within the UK, with occasional travel as required.

As Regulatory Lead, you will play a key role in driving and delivering clinical trial regulatory strategy across all phases (I–IV). This is a hands-on position where you will work cross-functionally across the business while also supporting and mentoring a small team.

Key Responsibilities

• Lead and define global regulatory strategies for clinical trials, with a strong understanding of the full drug development lifecycle (including PIPs and ODD).
• Manage and oversee CTA submissions (initial and amendments) across Europe, including full ownership of Clinical Trial Authorisation Applications (CTAAs).
• Take a leading role in CTR submissions, with a strong hands-on working knowledge of CTIS.
• Prepare and manage core clinical trial documentation, including the Master Core Dossier and country-level patient-facing materials (e.g., Informed Consent Forms).
• Support Study Start-Up (SSU) activities across phases I–IV trials.
• Track and manage submission progress through eTMF/CTMS systems.
• Support preparation for regulatory authority interactions (e.g., EMA, national agencies).
• Maintain up-to-date knowledge of oncology, clinical trial design, GCP, and regulatory guidance.
• Provide mentorship and line management to junior regulatory staff.

Requirements

• Bachelor’s degree (or equivalent) in a life sciences discipline.
• 8+ years’ experience within Regulatory Affairs, with strong CTA experience across multiple trial phases.
• Demonstrable experience leading CTR submissions and working with CTIS.
• Background within CRO and/or pharmaceutical environments.
• Previous oncology experience is essential.
• Prior line management or mentoring experience.

If you’d like to find out more, please send your CV to

Please NOTE this role does not offer job sponsorship, and you MUST hold the full right to work in the UK.

If this role isn’t quite right for you, feel free to share it with your network — we offer a £250 referral voucher if we successfully place someone you recommend.