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- Tasks: Lead Quality Assurance and Regulatory Affairs for a dynamic pharmaceutical company.
- Company: Established pharma firm with a focus on GI and hepatology.
- Benefits: Autonomous role with high visibility and career growth potential.
- Why this job: Make a real impact in a small team with innovative products.
- Qualifications: MHRA-approved RP/RPi experience and strong GMP/GDP background required.
- Other info: Flexible working with 2 days on-site in Maidenhead.
The predicted salary is between 36000 - 60000 £ per year.
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
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.
Quality Assurance & Regulatory Affairs Manager in Reading employer: CK Group
Contact Detail:
CK Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance & Regulatory Affairs Manager in Reading
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in Quality Assurance and Regulatory Affairs. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP/GDP and Quality Systems. We all know that confidence is key, so practice answering common interview questions related to your experience as an RP and RPi.
✨Tip Number 3
Don’t forget to showcase your expertise in Pharmacovigilance during interviews. Highlight any relevant experience you have with local PV compliance and oversight, as this will set you apart from other candidates.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and eager to join our team.
We think you need these skills to ace Quality Assurance & Regulatory Affairs Manager in Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance & Regulatory Affairs role. Highlight your experience with GMP/GDP and any relevant regulatory affairs work you've done. We want to see how your background fits perfectly with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for our team. Mention your experience as an RP and RPi, and how you can contribute to our mission in the pharmaceutical industry. Keep it engaging and personal!
Showcase Your Autonomy: Since this role requires a lot of independence, make sure to highlight instances where you've successfully operated autonomously in previous positions. We love seeing candidates who can take initiative and manage their responsibilities effectively!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at CK Group
✨Know Your Regulations
Make sure you brush up on your knowledge of UK regulations, especially those related to GMP/GDP and Pharmacovigilance. Being able to discuss specific guidelines and how they apply to the role will show that you're not just familiar with the basics but are ready to hit the ground running.
✨Showcase Your Experience
Prepare to share concrete examples from your past roles where you've acted as a Responsible Person or managed Quality Systems. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewer to see your impact.
✨Understand the Company’s Focus
Research the company’s portfolio, especially their focus on GI and hepatology. Being able to discuss how your experience aligns with their products and upcoming launches will demonstrate your genuine interest in the role and the company.
✨Prepare Questions
Have a list of thoughtful questions ready to ask at the end of the interview. This could include inquiries about their approach to regulatory changes or how they ensure compliance within their Quality Management System. It shows you're engaged and thinking critically about the role.
