At a Glance
- Tasks: Lead global regulatory strategies for clinical trials and mentor a small team.
- Company: Cutting-edge oncology-focused organisation with a collaborative culture.
- Benefits: Fully remote role with occasional travel and competitive salary.
- Other info: Opportunity for professional growth and a chance to shape the future of clinical trials.
- Why this job: Make a real impact in clinical trials while advancing your career in a dynamic environment.
- Qualifications: 8+ years in Regulatory Affairs with leadership experience and oncology background.
The predicted salary is between 60000 - 80000 € per year.
Location: UK, Remote – Travel 2x per year (Must be based and living in the UK)
We’re partnered with a cutting-edge, oncology-focused organisation delivering early- and late-phase clinical trials on a global scale, now looking to appoint a Regulatory Affairs Leader to join their growing team.
This is a fantastic opportunity for an experienced Regulatory professional to take ownership of global clinical trial strategy, working in a highly collaborative, science-driven environment. Being the Regulatory Leader, you will line manage a small team of two professionals and MUST have prior experience in leadership. The role is fully remote within the UK, with occasional travel as required.
As Regulatory Lead, you will play a key role in driving and delivering clinical trial regulatory strategy across all phases (I–IV). This is a hands-on position where you will work cross-functionally across the business while also supporting and mentoring a small team.
Key Responsibilities
- Lead and define global regulatory strategies for clinical trials, with a strong understanding of the full drug development lifecycle (including PIPs and ODD).
- Manage and oversee CTA submissions (initial and amendments) across Europe, including full ownership of Clinical Trial Authorisation Applications (CTAAs).
- Take a leading role in CTR submissions, with a strong hands-on working knowledge of CTIS.
- Prepare and manage core clinical trial documentation, including the Master Core Dossier and country-level patient-facing materials (e.g., Informed Consent Forms).
- Support Study Start-Up (SSU) activities across phases I–IV trials.
- Track and manage submission progress through eTMF/CTMS systems.
- Support preparation for regulatory authority interactions (e.g., EMA, national agencies).
- Maintain up-to-date knowledge of oncology, clinical trial design, GCP, and regulatory guidance.
- Provide mentorship and line management to junior regulatory staff.
Requirements
- Bachelor’s degree (or equivalent) in a life sciences discipline.
- 8+ years’ experience within Regulatory Affairs, with strong CTA experience across multiple trial phases.
- Demonstrable experience leading CTR submissions and working with CTIS.
- Background within CRO and/or pharmaceutical environments.
- Previous oncology experience is essential.
- Prior line management or mentoring experience.
If you’d like to find out more, please send your CV to.
Please NOTE this role does not offer job sponsorship, and you MUST hold the full right to work in the UK.
If this role isn’t quite right for you, feel free to share it with your network — we offer a £250 referral voucher if we successfully place someone you recommend.
Regulatory Affairs Lead - Clinical Trials in Stoke-on-Trent employer: Cpl Life Sciences
Join a pioneering oncology-focused organisation that values innovation and collaboration, offering a fully remote work environment within the UK. As a Regulatory Affairs Lead, you will not only drive global clinical trial strategies but also have the opportunity to mentor a dedicated team, fostering professional growth in a supportive culture. With occasional travel and a commitment to advancing cancer research, this role provides a meaningful and rewarding career path for experienced regulatory professionals.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Lead - Clinical Trials in Stoke-on-Trent
✨Network Like a Pro
Get out there and connect with people in the industry! Attend webinars, conferences, or local meetups. The more you engage, the better your chances of landing that Regulatory Affairs Lead role.
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back! Share your insights on clinical trial strategies and regulatory processes. We want to see your passion and knowledge shine through.
✨Tailor Your Approach
Every conversation is an opportunity. Make sure to tailor your discussions to highlight your leadership experience and oncology background. This will show that you’re the perfect fit for the role!
✨Apply Through Our Website
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step.
We think you need these skills to ace Regulatory Affairs Lead - Clinical Trials in Stoke-on-Trent
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that match the Regulatory Affairs Lead role. Highlight your leadership experience and any relevant oncology background to catch our eye!
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're the perfect fit for this position. Share your passion for clinical trials and how your previous experiences have prepared you for this role.
Showcase Your Achievements:Don’t just list your responsibilities; showcase your achievements in previous roles. Use metrics or specific examples to demonstrate how you've successfully led regulatory strategies or managed submissions.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of the drug development lifecycle, especially around Clinical Trial Authorisation Applications (CTAAs) and CTR submissions. Being able to discuss these topics confidently will show that you're not just familiar with the basics but are ready to lead.
✨Showcase Your Leadership Skills
Since this role involves line management, be prepared to share examples of how you've successfully led teams in the past. Think about specific challenges you faced and how you mentored your team through them. This will demonstrate your capability as a leader.
✨Prepare for Regulatory Authority Interactions
Familiarise yourself with the expectations and processes of regulatory authorities like the EMA. You might be asked how you would handle interactions or submissions, so having a clear strategy in mind will set you apart from other candidates.
✨Stay Current on Oncology Trends
Given the focus on oncology in this role, make sure you're up-to-date with the latest trends and regulations in the field. Being able to discuss recent developments or studies will show your passion and commitment to the area, making you a more attractive candidate.
