Quality Assurance Regulatory Affairs Manager

CK Group
Maidenhead
1 month ago
Applications closed

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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 .


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