Regulatory Affairs Consultant - Start-Up Biotech in Birmingham

Job Title: Regulatory Affairs Advisor – Gene Therapy (Fractional / Consultancy) Location: Remote (UK/EU/US-based candidates welcome) Engagement Type: Fractional / Consultancy | Flexible Hours
About the Opportunity An early-stage gene therapy company is seeking a seasoned Regulatory Affairs Advisor to guide its early-stage development strategy. This is a fractional role ideal for a senior regulatory expert with a track record of supporting pre-IND biotech companies in the cell and gene therapy (CGT) space across the UK, EU, and US. Key Responsibilities Provide strategic regulatory guidance from concept through preclinical and IND/CTA-enabling stages. Advise on regulatory pathways for gene therapy products in the UK (MHRA), EU (EMA), and US (FDA). Support the preparation of early engagement materials Ensure the company is building toward regulatory readiness with appropriate documentation, timelines, and risk mitigation. Collaborate closely with the founding team and scientific leads to align development plans with regulatory expectations.
Ideal Profile 15+ years of regulatory affairs experience, with a strong focus on gene therapy or ATMPs. Experience working with startups or emerging biotech in an advisory or fractional capacity. Demonstrated success in bringing early-stage biotech programs from preclinical through to IND/CTA submission. Deep knowledge of global regulatory frameworks, including MHRA, EMA, and FDA expectations for CGT products. Pragmatic, collaborative, and comfortable operating in a lean, fast-moving environment. Why Join? Shape the regulatory foundation of a high-potential gene therapy startup. Flexible, part-time engagement tailored to your availability. Work with a passionate, science-led founding team at a critical inflection point. Interested? Please reach out confidentially to Julia Bowden to learn more or express interest.
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