Senior Regulatory Advisor - Start-Up Fractional CDX

About the role

We are partnering with a confidential oncology biotech to appoint a Fractional Regulatory CDx Strategy Advisor. This senior‑level, part‑time consultancy will shape the companion diagnostic (CDx) strategy that underpins an innovative drug development programme.

Key responsibilities

• Define and execute CDx regulatory strategy across FDA (PMA, Q‑Sub, IDE, 510(k)) and EU IVDR pathways.
• Provide expert guidance on oncology biomarkers, translational medicine, molecular diagnostics, liquid biopsy and IHC assay development.
• Navigate global regulatory approval processes for precision‑medicine products.
• Collaborate closely with the drug development team to align diagnostic and therapeutic timelines.
• Report directly to the co‑founder and influence strategic decision‑making.

Required profile

• Proven experience taking a companion diagnostic through all stages of regulatory approval in a start‑up environment.
• Strong knowledge of both US and EU regulatory frameworks for diagnostics.
• Ability to work independently and provide high‑impact strategic advice.

Required skills

• FDA PMA pathway
• FDA Q‑Sub pathway
• FDA IDE pathway
• FDA 510(k) pathway
• EU IVDR regulatory knowledge
• Companion diagnostic strategy development
• Oncology biomarkers
• Translational medicine
• Molecular diagnostics
• Liquid biopsy techniques
• IHC assay expertise
• Global regulatory approval processes for precision medicine

What we offer

• Flexible consultancy engagement with significant strategic influence.
• Opportunity to work directly with senior leadership of a fast‑growing biotech.