Your newpany
This leading global biopharmaceuticalpany 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.
Your new role
Reporting to the Head of UK Regulatory, you will take ownership of one or more products of mediumplexity and strategic impact, working closely with UK, Ireland, and EU regulatory stakeholders.Key Responsibilities
1. Lead post-MAA lifecycle management activities for assigned products
2. Manageplex Type II variations and other regulatory procedures
3. Support and maintain Paediatric Investigation Plans (PIPs)
4. Contribute to clinical trial regulatory activities as required
5. Plan and execute local regulatory submissions in line with EMA, MHRA, and corporate standards.
6. Provide local regulatory input into global regulatory strategies
7. Ensure productpliance, including IMR, PMCs, and agencymitments
8. Develop and maintain local product labels in line with legislation and internal standards
9. Review promotional and non-promotional materials (where in scope)
10. Act as the primary point of contact with regulatory authorities
11. Support alignment between local regulatory requirements and global processes
What you'll need to succeed
12. Proven experience in UK/EU Regulatory Affairs within pharma or biotech
13. Strong background in post-approval regulatory lifecycle management
14. Demonstrated experience handling Type II variations
15. Hands-on experience with PIPs
16. Exposure to clinical trial regulatory submissions
17. Familiarity with Veeva Regulatory systems (preferred)
18. Experience working with centrally approved products via the EMA
What you'll get in return
Remote working