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 working with innovative oncology solutions.
- Qualifications: 8+ years in Regulatory Affairs with leadership experience and strong CTA knowledge.
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 Stockport 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 Stockport
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those with oncology experience. 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 clinical trial regulations and recent developments in oncology. We want you to shine when discussing your hands-on experience with CTA submissions and CTR processes.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've mentored junior staff and led teams in previous roles. We love to see candidates who can inspire and guide others in a collaborative environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate professionals like you to join our team.
We think you need these skills to ace Regulatory Affairs Lead - Clinical Trials in Stockport
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 the role.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you’re passionate about regulatory affairs and oncology. Share specific examples of your leadership experience and how you've successfully managed CTA submissions in the past.
Showcase Your Knowledge:Demonstrate your understanding of the drug development lifecycle and regulatory processes in your application. We want to see that you’re up-to-date with current regulations and have a solid grasp of GCP guidelines.
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss any important updates from us!
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 lead and support others effectively.
✨Prepare for Cross-Functional Collaboration
This position requires working across various departments, so think of instances 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, it's crucial to stay informed about the latest developments in this field. Bring up recent studies or regulatory changes during your interview to show your passion and commitment to staying current in the industry.
