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 jday@ckgroup.co.uk or call 01246 457719.