Quality Assurance Regulatory Affairs Manager

CK Group; Maidenhead; Hybrid; GBP 90,000 - 95,000; Full time

Job summary

A well-established pharmaceutical company in Maidenhead is seeking a Quality and Regulatory professional to play a crucial role in managing Quality Assurance and Regulatory Affairs. This autonomous position includes responsibilities such as acting as Responsible Person for the UK & Ireland, overseeing Pharmacovigilance, and ensuring compliance with quality management systems. Ideal candidates should have prior experience as an RP, strong GMP/GDP background, and familiarity with Regulatory Affairs in the UK. Competitive salary and benefits offered.

Qualifications

• MHRA-approved RP and RPi experience is essential.
• Strong background in GMP/GDP and Quality Systems.
• Solid Regulatory Affairs experience in the UK required.

Responsibilities

• Act as named RP and RPi under the WDA(H).
• Manage Quality Management System (GMP/GDP) effectively.
• Oversee CMOs, suppliers, and service providers.

Skills

Quality Assurance

Regulatory Affairs

Pharmacovigilance

Job description

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 [e-mail] or call 01246 457719.

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Quality Assurance Manager • Maidenhead, England, United Kingdom