Quality Assurance Regulatory Affairs Manager
3 hours ago
Maidenhead
A small, well-established pharmaceutical company is seeking a Quality and Regulatory professional to join its UK Medical Affairs team following a planned retirement. This is an autonomous role with primary responsibility for Quality Assurance and Regulatory Affairs, including acting as Responsible Person (RP) and Responsible Person Import (RPi) for the UK & Ireland. The position also includes local Pharmacovigilance oversight, operating within a global PV framework. Key responsibilities include: • Acting as named RP and RPi under the WDA(H), • Ownership and maintenance of the Quality Management System (GMP/GDP), • Oversight of CMOs, suppliers and service providers, • Regulatory lifecycle management for marketed and pre-launch products, • Advisory input on regulatory and quality impact of supply or product changes, • Local PV compliance and oversight (training, reporting, documentation) About the company: • Established pharmaceutical business with a strong GI and hepatology focus, • Portfolio across Rx products and branded generics, • Entering pre-launch for a first-in-class medicine, • Small UK affiliate with high autonomy and visibility Based in the Maidenhead area with 2 days a week on-site Salary banding - £90,000 - £95,000 plus benefits Key requirements: • MHRA-approved RP and RPi experience (essential), • Strong background in GMP/GDP and Quality Systems, • Solid Regulatory Affairs experience in the UK (Ireland exposure beneficial), • Working knowledge of Pharmacovigilance/GVP (oversight level), • Comfortable operating independently in a senior role If you’d like to explore this opportunity or know someone suitable, please feel free to message me directly on or call 01246 457719.