https://jobs.co.uk/job/fractional-regulatory-affairs-advisor-companion-diagnostics-hays-life-sciences--eda075f9-cfdf-4e53-a9b4-6c19077a7817 RSS feed for Fractional Regulatory Affairs Advisor - Companion Diagnostics at Hays Life Sciences. en-gb Fri, 17 Jul 2026 16:13:08 GMT https://jobs.co.uk/job/fractional-regulatory-affairs-advisor-companion-diagnostics-hays-life-sciences--eda075f9-cfdf-4e53-a9b4-6c19077a7817 https://jobs.co.uk/job/fractional-regulatory-affairs-advisor-companion-diagnostics-hays-life-sciences--eda075f9-cfdf-4e53-a9b4-6c19077a7817 Fri, 17 Jul 2026 11:52:03 GMT Location: City | Salary: 10000-500000 Annual | 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 strategyUS regulatory pathways including PMA, Q-Sub, IDE and 510(k)EU IVDR strategy and implementationBiomarker development and diagnostic evidence generationPrecision medicine and targeted oncology therapiesMolecular diagnostics, liquid biopsy and IHC-based assaysRegulatory strategy across drug-diagnostic co-development programmesWe''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 advise the leadership team on... Contract