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, competitive salary, and opportunities for professional growth.
- Other info: Remote work within the UK with occasional travel; referral bonus available.
- Why this job: Make a real impact in clinical trials while working with innovative teams.
- 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 lucy.kirkaldy@cpl.com.
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 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, all while enjoying a supportive culture that prioritises professional growth and development. 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
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space, especially those who have experience with 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 expert in the room, so practice articulating your experience with CTA submissions and CTR processes.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise. Use our website to find roles that excite you, and tailor your approach to show how you can contribute to their regulatory strategies.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind and show your enthusiasm for the role. Plus, it’s a great chance to reiterate why you’re the perfect fit for their team.
We think you need these skills to ace Regulatory Affairs Lead - Clinical Trials
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your regulatory affairs experience, especially in clinical trials, to show us you’re the right fit for this role.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you’re passionate about regulatory affairs and how your background aligns with our oncology-focused mission. This is your chance to showcase your personality and enthusiasm!
Showcase Leadership Experience:Since we’re looking for someone with prior leadership experience, make sure to highlight any relevant roles where you’ve managed teams or mentored others. We want to see how you can lead and inspire!
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves!
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 ownership of the regulatory strategy.
✨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 to manage and support others effectively.
✨Prepare for Cross-Functional Collaboration
This position requires working across various departments, so think of examples where you've collaborated with different teams. Be ready to discuss how you navigated any challenges and what strategies you used to ensure smooth communication and project success.
✨Stay Updated on Oncology Trends
Given the focus on oncology, make sure you're up-to-date with the latest trends and regulatory guidance in this area. Mentioning recent developments or changes in regulations during your interview can set you apart as a knowledgeable candidate who is genuinely interested in the field.
