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.Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.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 providersRegulatory lifecycle management for marketed and pre-launch productsAdvisory input on regulatory and quality impact of supply or product changesLocal PV compliance and oversight (training, reporting, documentation)About the company:Established pharmaceutical business with a strong GI and hepatology focusPortfolio across Rx products and branded genericsEntering pre-launch for a first-in-class medicineSmall UK affiliate with high autonomy and visibilityBased in the Maidenhead area with 2 days a week on-siteSalary banding - 90,000 - 95,000 plus benefitsKey requirements: xjdpvnf MHRA-approved RP and RPi experience (essential)Strong background in GMP/GDP and Quality SystemsSolid Regulatory Affairs experience in the UK (Ireland exposure beneficial)Working knowledge of Pharmacovigilance/GVP (oversight level)Comfortable operating independently in a senior roleIf youd like to explore this opportunity or know someone suitable, please feel free to message me directly on or call
Job Title
Quality Assurance Regulatory Affairs Manager