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.