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- Tasks: Lead regulatory activities for biopharmaceutical products and manage post-approval lifecycle.
- Company: Join a leading global biopharmaceutical company with a strong focus on innovation.
- Benefits: Enjoy remote working and a dynamic work environment.
- Other info: Collaborate with regulatory stakeholders across the UK, Ireland, and EU.
- Why this job: Make a significant impact in the biopharmaceutical industry while developing your career.
- Qualifications: Experience in UK/EU Regulatory Affairs and handling Type II variations required.
The predicted salary is between 50000 - 65000 £ per year.
This leading global biopharmaceutical company is looking for an experienced Regulatory Affairs Manager to join their UK Affiliate Regulatory team on a maternity cover basis. This is a high-impact role working on established products approved via the EMA Centralised Procedure, with strong exposure to post-approval lifecycle activities.
Reporting to the Head of UK Regulatory, you will take ownership of one or more products of medium complexity and strategic impact, working closely with UK, Ireland, and EU regulatory stakeholders.
Key Responsibilities- Lead post-MAA lifecycle management activities for assigned products
- Manage complex Type II variations and other regulatory procedures
- Support and maintain Paediatric Investigation Plans (PIPs)
- Contribute to clinical trial regulatory activities as required
- Plan and execute local regulatory submissions in line with EMA, MHRA, and corporate standards
- Provide local regulatory input into global regulatory strategies
- Ensure product compliance, including IMR, PMCs, and agency commitments
- Develop and maintain local product labels in line with legislation and internal standards
- Review promotional and non-promotional materials (where in scope)
- Act as the primary point of contact with regulatory authorities
- Support alignment between local regulatory requirements and global processes
- Proven experience in UK/EU Regulatory Affairs within pharma or biotech
- Strong background in post-approval regulatory lifecycle management
- Demonstrated experience handling Type II variations
- Hands-on experience with PIPs
- Exposure to clinical trial regulatory submissions
- Familiarity with Veeva Regulatory systems (preferred)
- Experience working with centrally approved products via the EMA
- Remote working
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. For more information on this or any other Regulatory Affairs contract jobs, please apply to this advert.
Regulatory Affairs Manager Uk and Ire in Uxbridge 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 Ire in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the biopharmaceutical industry, especially those 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 EMA and MHRA regulations. We want you to be ready to discuss how your experience aligns with the role's requirements, especially around post-approval lifecycle management.
✨Tip Number 3
Showcase your hands-on experience with Type II variations and PIPs during interviews. We know these are key aspects of the role, so highlight specific examples where you've successfully managed these processes.
✨Tip Number 4
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 that extra step to connect with us directly.
We think you need these skills to ace Regulatory Affairs Manager Uk and Ire in Uxbridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in UK/EU Regulatory Affairs, especially with post-approval lifecycle management. We want to see how your skills match the role, so don’t be shy about showcasing your relevant achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Regulatory Affairs Manager position. Mention specific experiences that relate to managing Type II variations and PIPs, as these are key aspects of the role.
Showcase Your Knowledge: In your application, demonstrate your understanding of EMA and MHRA standards. We love candidates who can speak the language of regulatory affairs, so drop in some relevant terminology and show us you know your stuff!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the easiest way for us to keep track of your application and ensures you get all the updates. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Hays Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of UK and EU regulatory affairs, especially around post-approval lifecycle management. Be ready to discuss your experience with Type II variations and Paediatric Investigation Plans (PIPs) in detail.
✨Showcase Your Strategic Impact
Prepare examples of how you've contributed to the strategic impact of products in your previous roles. Highlight specific instances where your input influenced regulatory submissions or compliance, as this will resonate well with the hiring team.
✨Familiarise Yourself with Veeva
If you have experience with Veeva Regulatory systems, make sure to mention it! If not, do a bit of research to understand how it works and be prepared to discuss how you can quickly adapt to new systems.
✨Engage with Regulatory Stakeholders
Think about how you've collaborated with regulatory authorities and other stakeholders in the past. Be ready to share your approach to maintaining those relationships and ensuring alignment between local and global processes.