Regulatory Affairs Consultant Cell Therapy - Outside IR35 in City of London

About the Company

Our client is a confidential, early-stage biotechnology company developing Cell Therapy targeting a major unmet need in an underserved patient population. The company is advancing its lead candidate toward first-in-human (FIH) clinical trials, with the goal of achieving early clinical proof of concept in both the US and EU.

The therapy has demonstrated meaningful outcomes in preclinical models, and the company is pursuing a rapid and strategic clinical development path to unlock value and address a growing global burden.

The Opportunity

We are seeking a highly experienced Regulatory Affairs Consultant with a strong background in cell and gene therapy to lead the development of an early regulatory strategy. This is a strategic and high-impact role that will shape the company\’s regulatory roadmap and clinical development trajectory.
Key Responsibilities

• Design and deliver a comprehensive early-stage regulatory strategy for US and EU markets.
• Provide expert guidance on regulatory pathways, clinical trial design, and interactions with health authorities.
• Lead or support the preparation of regulatory documentation, including pre-IND/Scientific Advice briefing packages.
• Advise on CMC, nonclinical, and clinical regulatory requirements specific to advanced therapies.
• Collaborate with internal leadership to align regulatory planning with scientific and business objectives.
• Represent the company in regulatory meetings with FDA, EMA, and other relevant agencies.

Ideal Candidate Profile

• 15+ years of regulatory affairs experience, with a strong focus on cell and gene therapy or advanced therapy medicinal products (ATMPs).
• Extensive experience creating early regulatory roadmaps for Cell and Gene Thearpy\’s in the US and EU.
• Demonstrated success in IND/CTA submissions and regulatory interactions in both the US and EU.
• Strong understanding of regenerative medicine regulations, including expedited pathways (e.g., RMAT, PRIME).
• Strategic mindset with the ability to work independently and influence cross-functional teams.
• Comfortable operating in a fast-paced, early-stage biotech environment.

Engagement Details

• An initial 18-30 hours per week commitment is expected during the regulatory strategy development phase for 1-3 months.
• Engagement will transition to more part-time as the company approaches key regulatory milestones. This will pick back up as they get closer to applications for the US and the EU.
• Flexible, remote working arrangement, but must be located in the UK

Why This Role?

• Shape the regulatory path of a first-in-class therapy addressing a significant unmet medical need.
• Join a mission-driven team at a pivotal stage of development.
• Contribute to a program with transformative clinical potential and strong commercial prospects.

To express interest or learn more, please contact:Julia Bowden or apply with your profile now.