Regulatory Consultant – Cell & Gene Therapy

🔬 Regulatory Consultant | Cell & Gene Therapy (ATMPs)

🕒 Engagement: Full‑time consulting for 3 months initially, then a long‑term arrangement

🧬 Sector: Cell Therapy | Stem Cells | GMP | Advanced Therapies

We are supporting a therapeutics company that is preparing to launch an advanced stem cell therapy platform. They are now seeking an experienced Regulatory Consultant to step in immediately and take ownership of regulatory remediation and stakeholder engagement.

This is a highly visible, high‑pressure engagement with strong backing and a clear mandate to act.

The brief

• Act as the primary regulatory lead and interface with MHRA
• Stabilise the regulatory position following inspection feedback
• Build, formalise and implement GMP and regulatory processes
• Support readiness for publication and launch activity
• Work closely with senior leadership, lab and clinical teams

Required experience

• Strong background in ATMPs / autologous stem cell therapies
• Hands‑on experience dealing directly with MHRA
• Deep GMP cell manufacturing expertise
• CQC experience is highly desirable
• Practical, delivery‑focused operator rather than advisory‑only
• Start: ASAP
• Initial term: 3 months, with a strong view to extension
• Location: London
• Day rate is highly competitive (budget approved)
• The right individual will be engaged immediately

This role is critical to the launch and is a good fit for someone comfortable working under pressure, with the credibility and judgement to manage regulators and implement change at pace.