At a Glance
- Tasks: Shape diagnostic strategy for innovative oncology programmes and guide regulatory pathways.
- Company: Confidential biotech firm focused on precision medicine and companion diagnostics.
- Benefits: Flexible working arrangements and the chance to influence cutting-edge healthcare solutions.
- Other info: Collaborate directly with senior leadership in a fast-paced start-up environment.
- Why this job: Join a dynamic team and make a real impact in the future of cancer treatment.
- Qualifications: Experience in regulatory affairs, particularly with companion diagnostics and oncology.
The predicted salary is between 60000 - 80000 £ per year.
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 sci...
Fractional Regulatory Affairs Advisor - Companion Diagnostics employer: Hays
Join a vibrant secondary school that prioritises excellence in education and fosters a supportive community for both students and staff. As the Head of Mathematics, you will benefit from a competitive salary, ongoing professional development opportunities, and a collaborative work culture that encourages innovation and growth. This role not only allows you to lead a dedicated team but also to make a significant impact on student achievement in a welcoming environment.
