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 Bolton 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 a commitment to excellence and a focus on impactful clinical research, this company stands out as an exceptional employer for those seeking meaningful contributions in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Lead - Clinical Trials in Bolton
✨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. We love seeing candidates who can inspire and guide their teams, especially in a collaborative environment like ours.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’re always on the lookout for passionate candidates who are eager to make an impact in the oncology field.
We think you need these skills to ace Regulatory Affairs Lead - Clinical Trials in Bolton
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 Relevant Experience:When filling out your application, make sure to emphasise your 8+ years in Regulatory Affairs. We want to see your hands-on experience with CTR submissions and your understanding of the drug development lifecycle. Don’t hold back on those achievements!
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 the role. Plus, it shows us you’re keen on joining our team!
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 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.
