At a Glance
- Tasks: Lead regulatory affairs and quality assurance for a growing pharmaceutical business.
- Company: Dynamic company focused on improving patient outcomes in the pharmaceutical sector.
- Benefits: Flexible working options, competitive salary, and opportunities for professional growth.
- Other info: Join a collaborative team dedicated to innovation and quality in healthcare.
- Why this job: Make a real impact in a mission-driven environment while shaping regulatory frameworks.
- Qualifications: 5+ years in regulatory affairs and QA management within sterile manufacturing.
The predicted salary is between 60000 - 75000 € per year.
Site-based with flexibility for some remote working in the long-term. Flexible - can be based out of Sheffield, Preston, Stoke-on-Trent or Manchester.
Are you an experienced QA and Regulatory professional ready to take on a pivotal leadership role within an exciting growing business? Our client is looking for a QA Regulatory Manager to oversee regulatory affairs for the UK business and assist with QA projects.
Reporting directly to the Head of Quality, this is a key strategic position interfacing with Quality Assurance, Regulatory Affairs, Operations and external regulators. You’ll play a critical role in shaping quality systems, ensuring inspection readiness, and supporting the development and supply of Investigational Medicinal Products (IMPs).
- Provide QA and regulatory leadership across all UK facilities, ensuring consistent application of GMP, GDP and MHRA requirements.
- Act as the regulatory lead for IMP development activities, including review and approval of IMPDs, clinical trial quality documentation and supply processes.
- Lead interactions with MHRA and other regulatory bodies, supporting inspections, audits, responses and ongoing compliance commitments.
- Ensure site licences, variations and regulatory submissions remain current and aligned with operational activities.
- Harmonise and strengthen quality systems across multiple sites, covering deviations, CAPAs, change control, documentation and risk management.
- Provide QA project support for product development, technology transfer and validation activities within sterile production environments.
- Review and approve quality documentation, including SOPs, validation protocols, batch records and development reports.
- Serve as subject matter expert for aseptic GMP, IMP manufacture and regulatory expectations.
Proven Regulatory Affairs experience within sterile manufacturing or aseptic environments (5 years+).
- Proven QA management experience.
- Strong working knowledge of UK/EU GMP, MHRA regulatory requirements and GxP compliance.
- Background in regulatory inspections, audits and authority interactions.
- Ability to work effectively with manufacturing, QC, development and clinical teams.
- Degree in a scientific discipline (or equivalent experience); further QA/regulatory qualifications are an advantage.
This is a rare opportunity to take on a high-impact role within a specialised and mission-driven aseptic pharmaceutical operation. You’ll shape the regulatory framework supporting both commercial products and innovative clinical development programmes—while working with a collaborative, highly skilled team committed to improving patient outcomes.
Regulatory Compliance Manager - Pensions in Manchester employer: RBW Consulting
Join a dynamic and mission-driven team as a Regulatory Compliance Manager in the heart of the UK, with flexible working options across Sheffield, Preston, Stoke-on-Trent, or Manchester. Our company fosters a collaborative work culture that prioritises employee growth and development, offering unique opportunities to lead regulatory affairs in a specialised aseptic pharmaceutical environment. With a commitment to improving patient outcomes, you'll be part of a supportive team that values innovation and excellence in quality assurance.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Compliance Manager - Pensions in Manchester
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory and QA fields. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP, MHRA requirements, and recent regulatory changes. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during the interview.
✨Tip Number 3
Showcase your leadership skills! Be ready to share examples of how you've successfully led QA projects or navigated regulatory challenges in the past. This will help potential employers see you as the strategic leader they need.
✨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 Regulatory Compliance Manager - Pensions in Manchester
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Compliance Manager role. Highlight your experience in QA and regulatory affairs, especially in sterile manufacturing or aseptic environments. We want to see how your background aligns with the job description!
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 role. Mention specific experiences that demonstrate your leadership in QA and regulatory compliance. We love a good story that showcases your skills!
Showcase Relevant Qualifications:Don’t forget to mention any relevant qualifications you have, especially those related to GMP, MHRA requirements, or GxP compliance. If you’ve got further QA or regulatory qualifications, flaunt them! We’re looking for someone who knows their stuff.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and keep track of it. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at RBW Consulting
✨Know Your Regulations
Make sure you brush up on UK/EU GMP, MHRA requirements, and GxP compliance. Being able to discuss these regulations confidently will show that you're not just familiar with the basics but are ready to lead in a regulatory capacity.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led QA projects or managed teams in previous roles. Highlight your experience in harmonising quality systems across multiple sites, as this is crucial for the role.
✨Be Ready for Technical Questions
Expect questions about IMP development activities and your experience with regulatory inspections and audits. Prepare to discuss specific challenges you've faced and how you overcame them, especially in sterile manufacturing environments.
✨Demonstrate Your Collaborative Spirit
This role requires working closely with various teams. Be prepared to talk about how you've effectively collaborated with manufacturing, QC, and clinical teams in the past. Show that you can bridge gaps and foster teamwork.
