Regulatory Affairs Consultant - Start-Up Biotech
| Dyddiad hysbysebu: | 06 Tachwedd 2025 |
|---|---|
| Cyflog: | £150 i £245.0 yr awr |
| Gwybodaeth ychwanegol am y cyflog: | Outside IR35 |
| Oriau: | Rhan Amser |
| Dyddiad cau: | 13 Tachwedd 2025 |
| Lleoliad: | City of London, London, EC2V6DN |
| Cwmni: | Hays Specialist Recruitment |
| Math o swydd: | Cytundeb |
| Cyfeirnod swydd: | 4741751_1762423110 |
Crynodeb
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.