At a Glance
- Tasks: Lead global regulatory strategies for clinical trials and manage submissions across Europe.
- Company: Cutting-edge oncology-focused organisation with a collaborative, science-driven culture.
- Benefits: Fully remote role, competitive salary, and opportunities for mentorship and leadership.
- Other info: Dynamic environment with opportunities for professional growth and development.
- Why this job: Make a real impact in clinical trials while leading a passionate team in oncology.
- Qualifications: 8+ years in Regulatory Affairs with strong CTA experience and leadership skills.
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 Plymouth 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 Plymouth
✨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 expert in the room, so practice articulating your experience with CTA submissions and CTR processes.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've mentored others in previous roles. Highlighting your ability to manage a team will set you apart as a strong candidate for the Regulatory Affairs Lead position.
✨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 and engaged with our platform.
We think you need these skills to ace Regulatory Affairs Lead - Clinical Trials in Plymouth
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 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, be 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:Don’t forget to submit your application through our website! It’s the best way for us to receive your details 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 take on a 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 others.
✨Prepare for Cross-Functional Collaboration
This position requires working across various departments, so think of examples where you've collaborated effectively with other teams. Highlight your communication skills and how you’ve navigated different perspectives to achieve common goals.
✨Stay Updated on Oncology Trends
Given the focus on oncology, it’s crucial to be aware of the latest trends and regulatory changes in this field. Bring up recent developments or guidelines during your interview to show that you’re proactive and genuinely interested in the area.
