At a Glance
- Tasks: Lead regulatory innovation in AI biotech, ensuring compliance and driving product development.
- Company: Join a cutting-edge AI biotech transforming drug development with innovative solutions.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to engage with industry leaders and regulators.
- Why this job: Make a real impact in the future of healthcare through AI-driven regulatory advancements.
- Qualifications: Master's degree in a technical field and 7 years of relevant experience required.
The predicted salary is between 63000 - 77000 £ per year.
- Job Type: Full-time, permanent
- Remuneration: Competitive salary and benefits
Cpl Life Sciences is partnering with a growing, innovative AI biotech operating at the interface of drug development and drug device development.
They are looking for a hands-on, pragmatic, and detail-oriented product lead focused on regulatory innovation.
A lean, execution-focused approach is critical.
The role is ideally suited to people with technical roots (AI/ML software development) who have grown into regulatory ownership within life sciences.
Your ambition will be to achieve lean process implementation as well as regulatory innovation, supporting the company's engagement with regulatory agencies for the acceptance of fit-for-purpose AI solutions.
The company builds generative AI solutions for clinical trials and clinical practice, spanning in vitro diagnostics, clinical decision support, and assessments embedded in late-stage clinical trials.
Its products operate at the intersection of several regulatory regimes, including IVDR, MDR/Sa MD, ICH E6 (R3) GCP, 21 CFR Part 11, the EU AI Act, and the emerging FDA and EMA frameworks for AI in drug development.
Responsibilities
- Lean (QMS) process advocacy
- Partner with the Quality Lead to ensure the Quality Management System (QMS) scales without crushing product velocity (efficient, low-burden, scalable and fit-for-purpose).
- Embed quality work into developer-native workflows, including retiring controls that are not supporting risk mitigation.
- Conversely, support the product teams in computerised system validation, from user requirements and risks to validation testing and acceptance criteria.
- Enable teams through training, templates and pragmatic guidance on regulatory expectations, without ever turning into the documentation team.
- Contribute to alignment across the QMS, information security (ISO 27001 / SOC 2) and HR/handbook frameworks so colleagues see one coherent system.
- Regulatory innovation and methodology
- Screen and monitor the relevant regulatory landscape with a focus on compliance, while evaluating opportunities to embed innovative AI solutions in drug development and clinical product strategies.
- Partner with the science and AI teams to (1) map innovations against regulatory opportunities, and (2) package methodological evidence into regulator-ready dossiers for qualification, submission and/or engagement with regulators.
- Represent the company in industry and regulator-facing forums on AI in clinical trials (FDA workshops, EMA stakeholder meetings, DIA, ICH working groups, etc.).
- Support engagement with regulators on the acceptability of new AI methodologies and their validation for clinical trials and/or clinical solutions, e. g.
FDA (Type B/C meetings, CDER/CBER), EMA (Scientific Advice, Innovation Task Force, CHMP qualification advice and qualification opinion procedures) and MHRA.
- Product management
- Translate user feedback, regulatory input, scientific literature and market insights into clear product requirements, improvements and acceptance criteria.
- Collaborate with the engineering, algorithm and science teams to shape the product roadmap.
- Own the product lifecycle from concept to launch and iteration, with clear stage-gates that satisfy commercial, scientific and regulatory needs.
- Monitor product performance and user outcomes and drive continuous improvements.
- Required skills and qualifications
Essential
- Master's degree in Engineering, Computer Science or a related technical discipline. An additional qualification in Quality or Regulatory Affairs is a plus.
- At least 7 years' combined experience in (technical) product ownership and regulatory, ideally AI-driven medical device software or clinical-trial computerised systems (with a focus on AI solutions) used in pivotal drug development.
- Strong understanding of quality management systems and relevant regulatory standards in relation to AI for both clinical practice and trials.
- Working knowledge of computerised system validation in clinical trials, ICH E6 (GCP), GAMP 5, ISO 13485, ISO 14971, IEC 62304 and 21 CFR Part 11.
Familiarity with AI-specific quality and risk frameworks: FDA AI/ML Sa MD Action Plan and FDA guidance on AI in drug development, EU AI Act, ISO/IEC 42001 and NIST AI RMF.
- Strong analytical and problem-solving skills, with a track record of creating low-burden processes for high-velocity product lifecycles.
- Technical roots in AI/ML implementation; able to engage credibly with engineers and data scientists on model architecture, data pipelines and validation.
- Entrepreneurial and empowered.
- Bonus
- Operational clinical-trial experience on the sponsor, CRO or regulator side.
- Proven track record of engaging with regulators to shape guidance on novel methodologies and contribute to evolving regulatory frameworks.
- Experience with information security guidelines (ISO 27001, SOC 2, etc.).
- Experience in preparing CE or FDA 510(k) / De Novo submissions.
- For more information, please reach out to me at lucy. kirkaldy@cpl. com
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Product Lead, Regulatory Innovation (AI) employer: CPL Group
Cpl Marketing is an exceptional employer that fosters a collaborative and supportive work culture, making it an ideal place for a Proposal Writer to thrive. With the flexibility of remote work and the opportunity to engage with a dynamic team in both Dublin and London, employees benefit from a strong emphasis on professional growth and development. The company values creativity and innovation, providing a platform for writers to produce impactful content that drives organisational success while enjoying a healthy work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Product Lead, Regulatory Innovation (AI)
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like CPL Group. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like CPL Group!
We think you need these skills to ace Product Lead, Regulatory Innovation (AI)
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show CPL Group that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at CPL Group.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that CPL Group does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at CPL Group
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at CPL Group. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into CPL Group's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at CPL Group. This shows your passion for the industry!
