https://jobs.co.uk/job/fractional-regulatory-affairs-advisor-companion-diagnostics-hays-life-sciences--0f336e1b-ce12-4f06-9b81-6c7d8cf5cef3 RSS feed for Fractional Regulatory Affairs Advisor - Companion Diagnostics at Hays Life Sciences. en-gb Thu, 16 Jul 2026 23:40:38 GMT https://jobs.co.uk/job/fractional-regulatory-affairs-advisor-companion-diagnostics-hays-life-sciences--0f336e1b-ce12-4f06-9b81-6c7d8cf5cef3 https://jobs.co.uk/job/fractional-regulatory-affairs-advisor-companion-diagnostics-hays-life-sciences--0f336e1b-ce12-4f06-9b81-6c7d8cf5cef3 Wed, 15 Jul 2026 23:00:00 GMT Location: City of London | Salary: Negotiable | Type: Contract | Confidential oncology biotech seeking a Fractional Regulatory CDx Strategy Advisor to help shape the diagnostic strategy alongside a precision medicine oncology programme. This is a highly strategic role, working directly with the co-founder and senior leadership team. The focus is not on submission execution, but on defining the regulatory pathway and evidence strategy needed to successfully develop and commercialise a companion diagnostic alongside the therapeutic asset. Key areas of expertise: Companion diagnostic (CDx) development and approval strategy US regulatory pathways including PMA, Q-Sub, IDE and 510(k) EU IVDR strategy and implementation Biomarker development and diagnostic evidence generation Precision medicine and targeted oncology therapies Molecular diagnostics, liquid biopsy and IHC-based assays Regulatory strategy across drug-diagnostic co-development programmes We''re looking for someone who has been through this before and understands what it takes to achieve the desired regulatory and commercial outcome. The ideal consultant will be able to challenge assumptions, identify risks early, influence study design and evidence generation plans, and adv... Contract