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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 opportunities.
- 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 48000 - 72000 £ 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:
- 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
Quality Assurance & Regulatory Affairs Manager - CK Group in Maidenhead employer: Jobster
Contact Detail:
Jobster Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance & Regulatory Affairs Manager - CK Group in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience 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 questions related to your expertise in regulatory affairs and pharmacovigilance.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for tailored opportunities that match your skills in Quality Assurance and Regulatory Affairs – it’s where the magic happens!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can set you apart from other candidates. It shows your enthusiasm for the role and keeps you fresh in the interviewer's mind as they make their decision.
We think you need these skills to ace Quality Assurance & Regulatory Affairs Manager - CK Group in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Quality Assurance and Regulatory Affairs role. Highlight your MHRA-approved RP and RPi experience, as well as your background in GMP/GDP and Quality Systems.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this autonomous role. Mention your solid Regulatory Affairs experience and how you can contribute to the team’s success in the UK Medical Affairs.
Showcase Your Independence: Since this role requires someone comfortable operating independently, make sure to include examples of past experiences where you've taken initiative or led projects. This will demonstrate your ability to thrive in a senior role.
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 this exciting opportunity in our small but dynamic team!
How to prepare for a job interview at Jobster
✨Know Your Regulations
Make sure you brush up on the latest regulations and guidelines relevant to Quality Assurance and Regulatory Affairs. Being able to discuss specific regulations, especially those related to MHRA, will show that you're not just familiar with the role but also passionate about compliance.
✨Showcase Your Experience
Prepare to share concrete examples from your past roles where you've successfully managed quality systems or regulatory affairs. Highlight any experience as a Responsible Person (RP) or Responsible Person Import (RPi), as this is crucial for the position.
✨Understand the Company’s Focus
Research the company’s portfolio, especially their focus on GI and hepatology. Being able to discuss how your skills can contribute to their specific products will demonstrate your genuine interest in the role and the company.
✨Prepare Questions
Have a few insightful questions ready to ask at the end of the interview. This could be about their approach to Pharmacovigilance or how they manage relationships with CMOs and suppliers. It shows that you’re thinking critically about the role and are eager to engage.
