At a Glance
- Tasks: Lead Quality Assurance and Regulatory Affairs for a dynamic pharmaceutical company.
- Company: Established pharma firm with a focus on GI and hepatology.
- Benefits: Competitive salary, autonomy, and opportunities for professional growth.
- Other info: Join a small team with a first-in-class medicine launch on the horizon.
- Why this job: Make a real impact in a senior role with high visibility.
- Qualifications: MHRA-approved RP/RPi experience and strong GMP/GDP background required.
The predicted salary is between 72000 - 84000 £ 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)
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
Based in the Maidenhead area with 2 days a week on-site. Salary banding - £90,000 - £95,000 plus benefits.
Quality Assurance Regulatory Affairs Manager in Newcastle upon Tyne employer: CK Group
Join a small yet well-established pharmaceutical company that values autonomy and offers a supportive work culture, perfect for professionals seeking meaningful contributions in Quality Assurance and Regulatory Affairs. With a strong focus on employee growth and development, this role provides the opportunity to lead critical projects within a dynamic team while enjoying the benefits of a competitive salary and flexible working arrangements in the Maidenhead area.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Regulatory Affairs Manager in Newcastle upon Tyne
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like CK Group. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like CK Group.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like CK Group. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what CK Group is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Quality Assurance Regulatory Affairs Manager in Newcastle upon Tyne
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at CK Group!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show CK Group that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at CK Group!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At CK Group, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at CK Group
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at CK Group that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with CK Group’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
