Your new company
You'll be joining a global specialty‑pharmaceutical organisation with a strong scientific foundation and a growing UK&I Affiliate team. The company operates across multiple therapeutic areas and is committed to high regulatory and quality standards. The UK team is lean, collaborative, and highly visible to global leadership, giving this role strategic influence across the affiliate.
Your new role
As the Head of Regulatory Affairs & Quality for the UK & Ireland, you will sit on the UK Senior Management Team and lead all Regulatory Affairs, Quality and local PV activities.You'll provide strategic direction across RA/QA/PV, manage licences (including MIA and WDA(H)), lead MHRA/HPRA interactions, ensure inspection readiness, oversee QMS performance, act as the local PV representative, and drive continuous improvement.You will also lead and develop the RA/QA team, manage consultants, support product launches, oversee market release responsibilities (including RP/RPi/QP‑related duties where required), and act as the key point of contact for both internal global partners and external regulatory authorities.
What you'll need to succeed
10+ years of combined Regulatory Affairs and Quality experience within UK/EU pharmaceuticals
RP or RPi registration (QP experience is a significant advantage)
Strong blend of regulatory lifecycle management and GMP/GDP quality leadership
Experience with MHRA inspections, licence management, and CAPA/quality system oversight
Strong understanding of PV requirements and experience overseeing outsourced PV partners
Hands‑on experience with QMS, deviations, complaints, PQRs, recalls, and inspection readiness
Experience with systems such as TrackWise, RIMS, GxP Suite and ideally SAP
Proven leadership across cross‑functional teams in matrix environments
Excellent risk management, prioritisation, and decision‑making capabilitiesWhat you'll get in return
You'll join a growing global pharma organisation with strong future investment and the autonomy to shape RA/QA/PV strategy for the UK & Ireland.You will gain senior leadership visibility, the opportunity to build and develop a high‑performing team, influence global processes, and directly impact compliance, product success and affiliate performance.This is a role with both strategic reach and hands‑on impact, ideal for someone wanting to lead change, improve systems, and elevate quality and regulatory standards across an entire affiliate.
What you need to do now
Please apply now and reach out to (url removed)