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 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 Crawley 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 Crawley
✨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 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 or led teams in previous roles. This is key for the Regulatory Affairs Lead position, so let your experience speak volumes.
✨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 looking for passionate candidates like you to join our team in this exciting field.
We think you need these skills to ace Regulatory Affairs Lead - Clinical Trials in Crawley
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, especially your leadership skills and CTA submissions. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about oncology and regulatory affairs. Share specific examples of your achievements and how they relate to the role. We love a good story!
Showcase Your Team Leadership:Since this role involves line management, be sure to highlight your leadership experience. Talk about how you've mentored others and led teams in the past. We’re looking for someone who can inspire and guide their team!
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 don’t miss any important updates. Plus, we love seeing applications come in through our platform!
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 processes but also passionate about them.
✨Showcase Your Leadership Skills
Since this role involves line management, be prepared to share examples of how you've successfully led a team in the past. Think about specific challenges you faced and how you motivated your team to overcome them. This will demonstrate your capability as a leader.
✨Prepare for Regulatory Authority Interactions
Familiarise yourself with the expectations and processes of regulatory authorities like the EMA. You might be asked how you would handle interactions with these agencies, so having a strategy in mind will help you stand out as a candidate who is ready for the role.
✨Be Ready to Discuss Oncology Experience
Given the focus on oncology in this position, be prepared to talk about your previous experiences in this area. Highlight any specific trials you've worked on and the impact they had. This will show that you understand the nuances of working in this specialised field.
