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 the co-founder in a collaborative environment.
- Why this job: Join a dynamic start-up and make a real impact in precision medicine.
- Qualifications: Proven CDx experience and strong knowledge of US and EU regulatory processes.
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'll 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're 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 in City of London employer: Hays Life Sciences
Join a pioneering oncology biotech that values innovation and expertise, offering a dynamic work environment where your contributions directly shape the future of precision medicine. With a strong focus on employee growth and a culture that encourages collaboration and strategic thinking, this role provides a unique opportunity to influence diagnostic strategies while working alongside industry leaders in a start-up setting. Enjoy the flexibility of consultancy engagement and the chance to make a meaningful impact in the field of oncology.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Advisor - Start-Up Fractional CDX in City of London
✨Network like a Pro
In the pharmaceutical industry, getting your foot in the door can often come down to who you know. So, connect with professionals through platforms like LinkedIn or attend industry-specific conferences and trade shows. These are golden opportunities to meet decision-makers and to showcase your expertise.
✨Show Off Your Expertise
As a freelancer, you really want to establish yourself as a go-to expert in your niche. Consider setting up a blog or contributing to pharmaceutical forums where you can share insights about trends and innovations. This will help increase your visibility and build credibility in the industry.
✨Join Freelance Platforms
Don't underestimate the power of freelance platforms that focus on the pharmaceutical sector. Websites like Upwork or industry-specific job boards can help you find gigs that match your skill set. Remember to tailor your profile to highlight your relevant experiences and credentials.
✨Leverage Your Local Networks
Since the pharmaceutical industry often hinges on relationships, reaching out to local universities or research institutions can lead to lead generation. They might have collaborations or projects looking for freelance talent. Plus, don’t forget to connect with local pharma associations for gigs and networking opportunities!
We think you need these skills to ace Senior Regulatory Advisor - Start-Up Fractional CDX in City of London
Some tips for your application 🫡
Showcase Your Expertise:In the pharmaceutical industry, it's super important to highlight your specific expertise. Make sure your CV or portfolio reflects your relevant experience—think clinical research, regulatory affairs, or drug development. Don’t forget to include any certifications or training you've completed that are particularly relevant to the role.
Include Case Studies or Project Samples:As a freelancer, your portfolio is your calling card. Include detailed case studies or samples from previous projects that highlight your contributions and results in the pharmaceutical sector. This could be anything from successful clinical trials you've worked on to regulatory submissions—use this to demonstrate your impact.
Articulate Your Availability and Rates:Freelance roles mean flexibility, so clarify your availability upfront. Be transparent about your rates too—this helps set the stage for negotiations. You can mention your preferred working hours and project lengths to align with what Hays Life Sciences might be looking for.
Tailor Your Cover Letter:Your cover letter should connect the dots between your experience and the needs of Hays Life Sciences. Use it to explain why you're interested in this freelance role specifically and how your background in the pharmaceutical industry can help solve their unique challenges. Let your personality shine through while remaining focused on professional achievements!
How to prepare for a job interview at Hays Life Sciences
✨Show Off Your Expertise
Freelancing in the pharmaceutical industry means you'll want to highlight your specialised knowledge. Make sure to showcase your experience with regulatory processes or clinical trials, as these are crucial in this field. Share specific projects you've worked on to demonstrate your capability!
✨Know Your Tools and Tech
If you've worked with any industry-specific software, like LabArchives or Empower, get ready to discuss your experience with them. Being familiar with these tools will set you apart during the interview, as they’re often central to project success in pharmaceuticals. Don’t forget to mention how you’ve used data analysis in your previous roles – it’s key in this sector!
✨Bring Your Portfolio to Life
As a freelancer, your portfolio is your calling card. Prepare a compelling presentation that outlines your previous projects, focusing on results and methodologies. Highlight any case studies or publications to show your contributions to research or development – this can really grab the attention of Hays Life Sciences.
✨Prepare for Scenario-Based Questions
Expect some scenario-based questions that might challenge your problem-solving skills in real-world contexts. Be ready to discuss how you would handle tight deadlines, regulatory hurdles, or unexpected findings in your projects. This will allow you to demonstrate not just your knowledge, but your practical abilities too!
