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    <title>Senior Regulatory Advisor - Start-Up Fractional CDX - Hays Life Sciences RSS Feed</title>
    <link>https://jobs.co.uk/job/senior-regulatory-advisor-start-up-fractional-cdx-hays-life-sciences--accf3afe-c6e7-4bc4-b811-633e03d82530</link>
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    <lastBuildDate>Sat, 04 Jul 2026 16:25:11 GMT</lastBuildDate>
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      <title>Senior Regulatory Advisor - Start-Up Fractional CDX - Hays Life Sciences</title>
      <link>https://jobs.co.uk/job/senior-regulatory-advisor-start-up-fractional-cdx-hays-life-sciences--accf3afe-c6e7-4bc4-b811-633e03d82530</link>
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      <pubDate>Sat, 04 Jul 2026 11:52:04 GMT</pubDate>
      <description>Location: City | Salary: 10000-500000 Annual | Type: Contract | 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:Companion diagnostic (CDx) strategyFDA pathways (PMA, Q-Sub, IDE, 510(k EU IVDR regulatory strategyOncology biomarkers and translational medicineMolecular diagnostics, liquid biopsy and IHC assaysGlobal regulatory approval pathways for precision medicine productsWe''re looking for someone with proven CDx experience in a start-up environment. Someone who has experience taking a Companion 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.</description>
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