Your newpany
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 andmercial 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 managingplex regulatory deliverables.
Key responsibilities may include:
1. Post‑approval lifecycle management (LCM) activities for UK & Ireland
2. Management ofplex Type II and other significant variations
3. Regulatory support for Paediatric Investigation Plans (PIPs)
4. Involvement in clinical trial regulatory activities
5. Review and approval of promotional and non‑promotional materials
6. Use of Veeva regulatory information management systems
What you'll need to succeed
7. Demonstrated experience withplex variations, including Type II
8. Proven experience in UK & Ireland affiliate regulatory affairs
9. Strong post‑MAA lifecycle management expertise for CP products
10. Exposure to PIPs and clinical trial regulatory submissions
11. Experience working with Veeva or similar regulatory systems
12. Excellentmunication skills and confidence working cross-functional
13. 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.