At a Glance
- Tasks: Lead regulatory compliance across multiple UK sites and ensure inspection readiness.
- Company: Dynamic pharmaceutical company with a focus on quality and innovation.
- Benefits: Flexible working options, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with opportunities to work across various teams.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring high-quality standards.
- Qualifications: Degree in Quality or Regulatory, with 5+ years of relevant experience.
Reporting to the Head of Quality UK, the Quality Assurance Regulatory Manager can be located at a choice of Company UK locations, with the opportunity for some remote working.
ROLE
- Providing regulatory leadership with accountability for regulatory compliance across seven UK licensed sites, ensuring consistent application of GMP, GDP and MHRA requirements.
- Key interface between Quality Assurance, Regulatory Affairs, Operations and external regulatory bodies, ensuring consistent standards, robust systems and inspection readiness across the network.
- Experience in commercial and investigational medicinal product (IMP) development, including early-phase and clinical trial supply within a sterile manufacturing environment.
- Combining strategic oversight with hands-on regulatory input, supporting routine commercial operations and development programmes.
- Deputise for Head of Quality for UK regulatory issues.
- Participate in site client audits and inspections by regulatory authorities.
- QA regulatory lead for commercial and IMP activities.
- Support regulatory interactions with MHRA and other authorities, including inspections, audits, responses and ongoing compliance commitments.
- Ensure site licences, variations and regulatory submissions are maintained and aligned with operational and development activities.
- Review and approve quality and regulatory documentation, including SOPs, batch documentation, validation protocols and development reports.
REQUIRED
- Degree or higher in Quality, or Regulatory, or equivalent experience in a pharmaceutical setting.
- Strong background in regulatory with a minimum of 5 years’ experience.
- Previous managerial or supervisory experience with a demonstrable track record of strong performance.
- Experience of pharmacovigilance is desirable.
- Proven regulatory experience within nuclear medicine, sterile manufacturing or aseptic processing environments.
- Demonstrable experience of supporting commercial and IMP product development, including clinical trial supply and IMPD preparation/review.
- Strong working knowledge of UK and EU GMP, MHRA regulatory requirements and GxP compliance.
- Experience working across multi-site operations, with the ability to implement consistent quality standards at scale.
- Background in regulatory inspections, audits and authority interactions within a licensed manufacturing environment.
- Experience collaborating cross-functionally with manufacturing, quality control, development and clinical teams.
- Confident communicator (spoken and written), with ability to operate at operational and senior stakeholder level.
- Experienced in Microsoft Windows, Word, Excel and PowerPoint.
QA Regulatory Manager in London employer: ARx Recruitment Services
As a Quality Control Technician, you will join a dynamic team dedicated to maintaining the highest standards of quality in our products. Our company fosters a collaborative work culture that values employee input and offers ample opportunities for professional growth and development. Located in a vibrant area, we provide competitive benefits and a supportive environment that makes us an excellent employer for those seeking meaningful and rewarding careers.
StudySmarter Expert Advice🤫
We think this is how you could land QA Regulatory Manager in London
✨Unlock Networking Opportunities
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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 ARx Recruitment Services.
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like ARx Recruitment Services. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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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 ARx Recruitment Services is looking for. A tailored application can really make you stand out!
We think you need these skills to ace QA Regulatory Manager in London
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 ARx Recruitment Services!
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 ARx Recruitment Services 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 ARx Recruitment Services!
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 ARx Recruitment Services, 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 ARx Recruitment Services
✨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 ARx Recruitment Services 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 ARx Recruitment Services’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.
