Senior Regulatory Advisor - Start-Up Fractional CDX

hays-gcj-v4-pd-online
📍 London, England, United Kingdom 💼 TEMPORARY 🕒 Posted July 07, 2026

Job Description

Confidential oncology biotech seeking a Fractional Regulatory CDx Strategy Advisor to help shape diagnostic strategy alongside an innovative drug development programme that they have.
You'll provide expert guidance on:
  • FDA pathways (PMA, Q-Sub, IDE, 510(k))
  • EU IVDR regulatory strategy
  • Oncology biomarkers and translational medicine
  • Molecular diagnostics, liquid biopsy and IHC assays
  • Global regulatory approval pathways for precision medicine products

  • We're looking for someone with proven CDx experience in a start-up environment. Someone who has experience taking apanion diagnostic through the stages of approval, strong US and EU regulatory knowledge.
    Flexible consultancy engagement with significant strategic influence reporting directly into the co-founder. #4810916 - Julia Bowden

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    Job Details

    • Location London, England
    • Job Type TEMPORARY
    • Category Business Operations Specialists
    • Posted Date July 07, 2026
    • Application Deadline August 16, 2026