At a Glance
- Tasks: Shape diagnostic strategies and guide regulatory pathways for innovative oncology products.
- Company: Confidential oncology biotech focused on cutting-edge drug development.
- Benefits: Flexible consultancy role with significant strategic influence and competitive compensation.
- Other info: Opportunity to work directly with co-founders in a fast-paced environment.
- Why this job: Join a dynamic start-up and make a real impact in precision medicine.
- Qualifications: Proven experience in companion diagnostics and strong US/EU regulatory knowledge.
The predicted salary is between 80000 - 100000 £ per year.
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 will 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 are 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.
Senior Regulatory Advisor - Start-Up Fractional CDX employer: Hays Life Sciences
Join a pioneering oncology biotech that values innovation and expertise, offering a dynamic work environment where your contributions directly impact the future of precision medicine. With a strong focus on employee growth and flexible consultancy engagements, you will thrive in a culture that encourages collaboration and strategic influence, all while working alongside passionate professionals dedicated to advancing healthcare solutions. Located in a vibrant start-up ecosystem, this role provides unique opportunities to shape diagnostic strategies and drive meaningful change in the industry.
