Regulatory Affairs Consultant-UK CTA

We are looking for an experienced UK Clinical Trial Application (CTA) Regulatory Affairs Consultant to provide hands-on regulatory support for an upcoming Phase 1 First-in-Human (FIH) clinical trial submission in the UK .

This is not an entry-level position . We are specifically looking for a regulatory professional with recent, practical UK CTA experience who can hit the ground running from Day 1 and independently support the submission through the MHRA/HRA and IRAS process , including management of Requests for Further Information (RFIs) .

Key Responsibilities

• Provide expert regulatory guidance on the current UK clinical trial regulatory framework and CTA requirements

• Develop and advise on the regulatory strategy for a Phase 1 FIH small-molecule clinical trial

• Lead/support preparation, review and submission of the UK CTA through IRAS

• Review the CTA submission package for regulatory completeness, quality and consistency

• Provide expert input into key submission documentation, including protocol, Investigator’s Brochure, IMPD, informed consent/PIS documents and supporting regulatory documentation

• Advise on UK-specific requirements for Phase 1/FIH studies , including MHRA and Research Ethics Committee expectations

• Coordinate and support MHRA/HRA/REC queries and RFIs , including preparation and review of responses

• Identify potential regulatory issues or submission gaps proactively and recommend practical solutions

• Support the submission through regulatory review and approval, working closely with internal teams, CROs and other stakeholders

• Ensure activities remain aligned with current UK clinical trial legislation, MHRA guidance, HRA requirements and applicable GCP standards

Essential Experience

We are looking for someone with:

✓ Strong, demonstrable UK Regulatory Affairs experience in clinical trials

✓ Recent hands-on experience preparing and submitting UK CTAs through IRAS

✓ Direct experience with MHRA and HRA/REC submissions and interactions

✓ Experience supporting Phase 1 and preferably First-in-Human (FIH) clinical trials

✓ Strong understanding of CTA documentation and IMPD requirements

✓ Practical experience responding to MHRA/HRA/REC RFIs or regulatory queries

✓ Ability to independently review a submission package and identify regulatory gaps or risks

✓ Up-to-date knowledge of the current UK clinical trial regulatory framework and submission process

✓ Excellent written communication, document-review and stakeholder-management skills

Small-molecule Phase 1/FIH experience would be highly desirable.

Who We’re Looking For

This role would suit a Senior Regulatory Affairs Consultant, Regulatory Affairs Manager/Director, or experienced independent regulatory consultant who has personally managed UK CTA submissions and is comfortable taking ownership of activities with minimal supervision.

We are particularly interested in professionals who have recently completed UK Phase 1/FIH CTA submissions and managed MHRA/HRA questions through to approval .