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For Companies At a Glance
- Tasks: Manage post-approval regulatory activities and collaborate with stakeholders in the UK & Ireland.
- Company: Join a leading biopharmaceutical organisation with a strong global presence.
- Benefits: 12-month contract with potential extension and opportunities for professional growth.
- Other info: Work collaboratively in a supportive team and attend the Cambridge office monthly.
- Why this job: Make a real impact in regulatory affairs within a dynamic and innovative environment.
- Qualifications: Experience in regulatory affairs, particularly with complex variations and lifecycle management.
The predicted salary is between 50000 - 60000 £ per year.
Your new company
You'll be joining a leading, research‑driven biopharmaceutical organisation with a strong UK & Ireland presence and large global footprint. The business manages a robust portfolio of centrally approved medicines and continues to invest in regulatory capability to support post‑approval lifecycle management and commercial growth across the UK&I markets.
Your new role
This is a Regulatory Affairs Manager mat cover position on a 12‑month contract, with the possibility of extension. The role sits within the UK & Ireland Regulatory Affairs function, reporting into the Head of UK Regulatory Affairs within the affiliate team. The position will focus on post‑approval regulatory activities for centrally authorised (CP) products, with close collaboration across UK & Ireland stakeholders. The role will primarily support products within RRMS and will involve managing complex regulatory deliverables.
Key responsibilities may include:
- Post‑approval lifecycle management (LCM) activities for UK & Ireland
- Management of complex Type II and other significant variations
- Regulatory support for Paediatric Investigation Plans (PIPs)
- Involvement in clinical trial regulatory activities
- Review and approval of promotional and non‑promotional materials
- Use of Veeva regulatory information management systems
What you'll need to succeed
- Demonstrated experience with complex variations, including Type II
- Proven experience in UK & Ireland affiliate regulatory affairs
- Strong post‑MAA lifecycle management expertise for CP products
- Exposure to PIPs and clinical trial regulatory submissions
- Experience working with Veeva or similar regulatory systems
- Excellent communication skills and confidence working cross-functional
- A collaborative, hands-on approach with a willingness to support across the wider team
The ideal start date is end of July / early August, and candidates should be local to, or able to attend, the Cambridge office once per month.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact Julia Bowden for a confidential discussion about your career.
Regulatory Affairs Manager UK and Ireland - Contract in Cambridge employer: Hays Life Sciences
Contact Detail:
Hays Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager UK and Ireland - Contract in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the biopharmaceutical industry, especially those who have experience in regulatory affairs. 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 post-approval lifecycle management and complex variations. We want you to feel confident discussing your experience with Type II variations and PIPs, so practice makes perfect!
✨Tip Number 3
Showcase your collaborative spirit! During interviews, highlight examples of how you've worked cross-functionally in previous roles. This will demonstrate that you're not just a lone wolf but a team player ready to support the wider team.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining our team and contributing to our mission in the UK & Ireland.
We think you need these skills to ace Regulatory Affairs Manager UK and Ireland - Contract in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, especially with complex variations and lifecycle management. We want to see how your skills align with the role, so don’t be shy about showcasing relevant projects!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this Regulatory Affairs Manager position. Share specific examples of your past experiences that relate to the job description.
Showcase Your Communication Skills: Since this role involves collaboration across teams, make sure to highlight your communication skills in your application. We love candidates who can articulate their thoughts clearly and work well with others!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team!
How to prepare for a job interview at Hays Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of post-approval lifecycle management and complex variations, especially Type II. Familiarise yourself with the specific regulatory requirements in the UK and Ireland, as well as any recent changes that might affect the role.
✨Showcase Your Experience
Prepare to discuss your previous experience with centrally approved products and how you've managed complex regulatory deliverables. Be ready to provide examples of your work with Paediatric Investigation Plans and clinical trial submissions to demonstrate your expertise.
✨Familiarity with Veeva is Key
Since the role involves using Veeva or similar regulatory systems, make sure you can talk about your experience with these tools. If you’ve used Veeva before, highlight specific projects where it played a crucial role in your regulatory processes.
✨Communication is Crucial
As this position requires collaboration across various teams, practice articulating your thoughts clearly and confidently. Think of examples where your communication skills helped resolve issues or facilitated teamwork, as this will show you're a great fit for their collaborative culture.