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- Tasks: Lead Regulatory Affairs, Quality, and PV activities for the UK & Ireland.
- Company: Join a global specialty-pharmaceutical organisation with a strong scientific foundation.
- Benefits: Shape strategy, gain senior leadership visibility, and build a high-performing team.
- Why this job: Make a real impact on compliance and product success in a growing organisation.
- Qualifications: 10+ years in Regulatory Affairs and Quality within UK/EU pharmaceuticals.
- Other info: Dynamic role with strategic influence and hands-on impact.
The predicted salary is between 36000 - 60000 £ per year.
You will be joining a global specialty-pharmaceutical organisation with a strong scientific foundation and a growing UK&I Affiliate team. The company operates across multiple therapeutic areas and is committed to high regulatory and quality standards. The UK team is lean, collaborative, and highly visible to global leadership, giving this role strategic influence across the affiliate.
As the Head of Regulatory Affairs & Quality for the UK & Ireland, you will sit on the UK Senior Management Team and lead all Regulatory Affairs, Quality and local PV activities. You will provide strategic direction across RA/QA/PV, manage licences (including MIA and WDA(H)), lead MHRA/HPRA interactions, ensure inspection readiness, oversee QMS performance, act as the local PV representative, and drive continuous improvement. You will also lead and develop the RA/QA team, manage consultants, support product launches, oversee market release responsibilities (including RP/RPi/QP-related duties where required), and act as the key point of contact for both internal global partners and external regulatory authorities.
What you’ll need to succeed:
- 10+ years of combined Regulatory Affairs and Quality experience within UK/EU pharmaceuticals
- RP or RPi registration (QP experience is a significant advantage)
- Strong blend of regulatory lifecycle management and GMP/GDP quality leadership
- Experience with MHRA inspections, licence management, and CAPA/quality system oversight
- Strong understanding of PV requirements and experience overseeing outsourced PV partners
- Hands-on experience with QMS, deviations, complaints, PQRs, recalls, and inspection readiness
- Experience with systems such as TrackWise, RIMS, GxP Suite and ideally SAP
- Proven leadership across cross-functional teams in matrix environments
- Excellent risk management, prioritisation, and decision-making capabilities
What you’ll get in return:
You will join a growing global pharma organisation with strong future investment and the autonomy to shape RA/QA/PV strategy for the UK & Ireland. You will gain senior leadership visibility, the opportunity to build and develop a high-performing team, influence global processes, and directly impact compliance, product success and affiliate performance. This is a role with both strategic reach and hands-on impact, ideal for someone wanting to lead change, improve systems, and elevate quality and regulatory standards across an entire affiliate.
Please apply now and reach out to (url removed).
Head of Quality, Regulatory, and PV UK&I in Maidenhead employer: Hays Life Sciences
Contact Detail:
Hays Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Quality, Regulatory, and PV UK&I in Maidenhead
✨Tip Number 1
Network like a pro! Connect with industry professionals on LinkedIn and attend relevant events. We can’t stress enough how important it is to build relationships that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practising common interview questions and tailoring your answers to highlight your experience in regulatory affairs and quality management.
✨Tip Number 3
Showcase your leadership skills! When discussing your experience, focus on examples where you’ve led teams or projects. We want to see how you can influence and drive change in a strategic role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Head of Quality, Regulatory, and PV UK&I in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your 10+ years of experience in Regulatory Affairs and Quality, and don’t forget to mention any hands-on experience with QMS and MHRA inspections.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Head of Quality, Regulatory, and PV role. Share examples of how you've led teams and improved systems in previous roles, and show us your passion for the pharmaceutical industry.
Showcase Your Leadership Skills: Since this role involves leading a team, make sure to highlight your leadership experience. Talk about how you've managed cross-functional teams and influenced strategic decisions in your past roles. We want to see your ability to drive change and elevate standards!
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. Don’t miss out on the chance to join our growing team!
How to prepare for a job interview at Hays Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of UK and EU regulatory frameworks, especially around MHRA inspections and licensing. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics but are ready to lead.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led cross-functional teams in the past. Highlight your experience in managing consultants and developing high-performing teams, as this role requires strong leadership capabilities. Use the STAR method to structure your responses.
✨Demonstrate Continuous Improvement Mindset
Be ready to discuss how you've driven continuous improvement in previous roles. Share specific instances where you've implemented changes that enhanced quality systems or regulatory compliance. This will resonate well with the company's commitment to high standards.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's strategic direction in RA/QA/PV and how they envision the role evolving. This shows your genuine interest in the position and helps you gauge if the company aligns with your career goals.