Fractional Regulatory Affairs Advisor - Companion Diagnostics

Confidential oncology biotech seeking a Fractional Regulatory CDx Strategy Advisor to help shape the diagnostic strategy alongside a precision medicine oncology programme.

This is a highly strategic role, working directly with the co-founder and senior leadership team. The focus is not on submission execution, but on defining the regulatory pathway and evidence strategy needed to successfully develop and commercialise a companion diagnostic alongside the therapeutic asset.
Key areas of expertise:

• Companion diagnostic (CDx) development and approval strategy
• US regulatory pathways including PMA, Q-Sub, IDE and 510(k)
• EU IVDR strategy and implementation
• Biomarker development and diagnostic evidence generation
• Precision medicine and targeted oncology therapies
• Molecular diagnostics, liquid biopsy and IHC-based assays
• Regulatory strategy across drug-diagnostic co-development programmes

We're looking for someone who has been through this before and understands what it takes to achieve the desired regulatory and commercial outcome.

The ideal consultant will be able to challenge assumptions, identify risks early, influence study design and evidence generation plans, and advise the leadership team on the most effective route to approval. They should be comfortable working in a start-up environment where regulatory strategy is being built alongside the science.

Experience taking a companion diagnostic from development through regulatory approval, with strong FDA and EU regulatory expertise, is essential.

Flexible consultancy engagement (3-8 hours per week) with significant strategic influence and direct access to the co-founder.