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) 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. ..... full job details .....