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.