Senior Regulatory Advisor - Start-Up Fractional CDX
other jobs Hays Specialist Recruitment Limited
Added before 1 Days
- England,London,City of London
- Part Time, Temporary
- Competitive salary
Job Description:
Full job descriptionConfidential 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) strategy
*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 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.
You’ll provide expert guidance on:
*Companion diagnostic (CDx) strategy
*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 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.
Job number 3910956
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Company Details:
Hays Specialist Recruitment Limited
At Hays we invest in lifelong partnerships that empower people and businesses to succeed. With over 50 years? success under our belts and a workforce ...