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 consultancy hours, strategic influence, and direct access to leadership.
- Other info: Dynamic start-up environment with opportunities to challenge norms and drive innovation.
- Why this job: Make a real impact in oncology by guiding regulatory strategies for groundbreaking diagnostics.
- Qualifications: Expertise in companion diagnostics, FDA/EU regulations, and strategic advisory experience.
The predicted salary is between 63000 - 77000 £ 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 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.
Fractional Regulatory Affairs Advisor - Companion Diagnostics in London employer: All The Top Bananas
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StudySmarter Expert Advice🤫
We think this is how you could land Fractional Regulatory Affairs Advisor - Companion Diagnostics in London
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We think you need these skills to ace Fractional Regulatory Affairs Advisor - Companion Diagnostics in London
Some tips for your application 🫡
Show Off Your Lab Skills:When applying for a freelance gig in biotechnology, make sure to highlight any lab techniques or processes you're familiar with—think PCR, sequencing, or even cell culture! This industry is all about those hands-on skills, so don’t shy away from detailing your experience in your CV.
Put Your Projects in the Spotlight:Creating a strong portfolio is key for freelance roles. Make sure to include any relevant projects you've worked on, whether they were for school, previous jobs, or personal research. This is your chance to showcase your expertise, so detail your contributions and the outcomes!
Tailor Your Rates to the Industry:When applying for freelance positions, be upfront about your rates but also consider the industry standards. Research what others in the biotech space are charging and adjust your pricing accordingly, so you're competitive while still recognising your worth.
Make Your Availability Clear:As a freelancer, it's crucial to outline your availability in your application. Let All The Top Bananas know when you can start and how many hours per week you can dedicate to the project. Being clear about your schedule shows your organisational skills and commitment right from the get-go.
How to prepare for a job interview at All The Top Bananas
✨Show Off Your Lab Skills
For a freelance gig in biotechnology, it’s crucial to demonstrate your practical lab skills. Bring along a portfolio showcasing your past projects, experiments, or publications that highlight your proficiency with techniques like PCR, gel electrophoresis, or CRISPR. This tangible evidence can make you stand out in a field that highly values hands-on experience.
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✨Flexibility is Key
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