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: Dynamic environment 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 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 [contact information]. 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 Warrington 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 and science-driven culture. With occasional travel and a commitment to employee development, this role provides a unique chance to make a significant impact in the field of clinical trials.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Lead - Clinical Trials in Warrington
✨Network Like a Pro
Get out there and connect with people in the industry! Attend webinars, join LinkedIn groups, or even hit up local meetups. The more you engage, the better your chances of landing that Regulatory Affairs Lead role.
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back! Share your insights on clinical trial strategies and regulatory processes. We want to see your passion for oncology and how you can lead a team effectively.
✨Tailor Your Approach
Every conversation is an opportunity! Make sure to tailor your discussions to highlight your experience with CTA submissions and mentoring. This will show that you’re not just another candidate, but the perfect fit for the role.
✨Apply Through Our Website
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Regulatory Affairs Lead - Clinical Trials in Warrington
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 Management Skills:Since this role involves line management, be sure to highlight your experience mentoring and leading teams. We’re looking for someone who can inspire others, so share any relevant examples that demonstrate your leadership style.
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 out on any important updates. Plus, we love seeing applications come in through our own 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 basics but are ready to take on the leadership role.
✨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 inspire others.
✨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.
