Senior Regulatory Advisor - Start-Up Fractional CDX - #2101179
Hays Specialist Recruitment Limited
Date: 15 hours ago
City: London
Contract type: Part time
Work schedule: Full day
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.
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