Senior Regulatory Advisor - Start-Up Fractional CDX - Job

Senior Regulatory Advisor - Start-Up Fractional CDX

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) 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

Apply Now

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