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- Tasks: Lead regulatory affairs and quality assurance for a growing pharmaceutical company.
- Company: Dynamic pharmaceutical business focused on improving patient outcomes.
- 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 55000 - 65000 £ 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.
COMPLIANCE MANAGER - PENSION in Manchester employer: RBW Consulting
Contact Detail:
RBW Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land COMPLIANCE MANAGER - PENSION in Manchester
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Compliance Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP, MHRA regulations, and QA processes. We recommend practising common interview questions related to regulatory affairs and quality assurance. Show them you’re the expert they need!
✨Tip Number 3
Don’t forget to showcase your leadership skills! When discussing your experience, highlight instances where you’ve led teams or projects, especially in compliance and regulatory settings. We want to see how you can drive quality systems across multiple sites.
✨Tip Number 4
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. Let’s get you one step closer to that exciting role in regulatory affairs!
We think you need these skills to ace COMPLIANCE MANAGER - PENSION in Manchester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the 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!
Showcase Relevant Qualifications: Don’t forget to mention any relevant qualifications you have, especially those related to QA and regulatory affairs. If you’ve got further certifications, let us know! It shows your commitment to the field.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. We can’t wait to hear from you!
How to prepare for a job interview at RBW Consulting
✨Know Your Regulations
Make sure you brush up on UK/EU GMP, MHRA regulatory requirements, and GxP compliance. Being able to discuss these in detail will show that you're not just familiar with the regulations but can also apply them effectively in a QA and regulatory context.
✨Showcase Your Leadership Skills
As a Compliance Manager, you'll be leading teams and interfacing with various departments. Prepare examples of how you've successfully led projects or teams in the past, especially in sterile manufacturing or aseptic environments. This will demonstrate your capability to take on a pivotal leadership role.
✨Prepare for Technical Questions
Expect questions about specific QA processes, IMP development activities, and regulatory interactions. Be ready to discuss your experience with audits, inspections, and how you've handled compliance challenges. This is your chance to shine as a subject matter expert!
✨Align with Company Values
Research the company’s mission and values, especially their commitment to improving patient outcomes. During the interview, express how your personal values align with theirs and how you can contribute to their goals. This connection can set you apart from other candidates.