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 work, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with occasional travel and excellent career advancement opportunities.
- Why this job: Make a real impact in clinical trials while leading a passionate team.
- 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.
- 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 Coventry 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 Coventry
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space, especially those who have experience in clinical trials. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of the drug development lifecycle and recent regulatory changes. We want you to be the go-to person for all things regulatory during your interview!
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've mentored others or led teams in previous roles. This is key for the Regulatory Affairs Lead position, so let your experience shine.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Affairs Lead - Clinical Trials in Coventry
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Lead role. Highlight your experience in clinical trials and leadership, as these are key for us. Use specific examples that showcase your skills in managing CTA submissions and working with CTIS.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Tell us why you're passionate about oncology and how your background fits the role. Be sure to mention your experience in leading teams and driving regulatory strategies, as this will resonate with us.
Showcase Your Knowledge:We want to see that you’re up-to-date with the latest in oncology and regulatory guidance. Mention any relevant training or certifications you have, and don’t hesitate to include insights on how you’ve applied this knowledge in past roles.
Apply Through Our Website:To make sure your application gets to us directly, apply through our website. It’s the best way for us to keep track of your application and ensure it reaches the right people. Plus, we love seeing candidates who take that extra step!
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 take on the leadership role.
✨Showcase Your Leadership Skills
Since this role involves line management, be prepared to share specific examples of how you've successfully led teams in the past. Think about challenges you've faced and how you mentored junior staff. This will demonstrate your capability to manage and inspire a team effectively.
✨Prepare for Cross-Functional Collaboration
This position requires working across various departments, so think of examples where you've collaborated with different teams. Highlight your communication skills and how you’ve navigated complex projects, as this will be key in a science-driven environment.
✨Stay Updated on Oncology Trends
Given the focus on oncology, make sure you're aware of the latest trends and regulatory changes in this field. Being able to discuss recent developments or guidelines will show your passion and commitment to staying informed, which is crucial for a Regulatory Affairs Lead.
