At a Glance
- Tasks: Lead global labelling initiatives and ensure compliance with regulations.
- Company: Join a global leader in the Life Sciences industry.
- Benefits: Competitive pay, remote work options, and professional growth opportunities.
- Other info: Dynamic role with opportunities for cross-functional collaboration and career advancement.
- Why this job: Make a real impact on product safety and compliance across the globe.
- Qualifications: 7+ years in project management with a focus on regulatory affairs.
The predicted salary is between 54000 - 60000 £ per year.
Location: Basingstoke (Remote with 1x month on-site meeting attendance required)
Pay Rate: £27.00 per hour
Contract Duration: 9 months initially (40 hours per week)
Start Date: ASAP
Position Overview
Are you an expert project leader ready to steer high-impact compliance initiatives for a global leader? We are seeking a Quality and Regulatory Labelling Program Manager to lead the execution of enterprise-wide labelling initiatives. In this role, you will ensure compliant, accurate, and globally harmonised product labelling across regulated markets.
Operating as an internal program leader, you will partner with global networks across Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain, and Marketing. This role is vital for strengthening labelling governance, managing complex change controls, ensuring inspection readiness, and implementing innovative business solutions.
Key Responsibilities
- Program Leadership & Governance: Define program deliverables, timelines, and success metrics for global labelling initiatives. Orchestrate program governance, including labelling review boards, PMO sessions, and change control meetings.
- Regulatory Compliance: Oversee the implementation of product labelling changes driven by regulatory updates, safety notices, or market expansions. Ensure strict compliance with global standards, including FDA, EU MDR/IVDR, ISO, GMP, and UDI requirements.
- Risk & Change Management: Proactively identify and monitor program risks (e.g., labelling errors, supply chain disruptions) and implement mitigation plans. Track corrective actions, commitments, and regulatory milestones.
- Cross-Functional Collaboration: Manage integrated project plans, schedules, and resources across geographically distributed teams. Build strong working relationships across technical and commercial functions to drive alignment.
- Inspection Readiness & Continuous Improvement: Support regulatory inspections and internal audits. Drive process standardisation and continuous improvement methodologies to improve operational excellence and workflow efficiency.
Education & Certifications & Experience:
- Bachelor's and/or Master's degree in Quality, Regulatory Affairs, Life Sciences, Engineering, Business, or a related field.
- Preferred: PMP (or equivalent) project management certification; ASQ certifications (CQE, CQA, CMQ/OE); Regulatory Affairs Certification (RAC); or Lean Six Sigma certification.
- 7+ years of experience managing complex programs and strategic initiatives.
- Strong background within Life Sciences, Medical Devices, Diagnostics, Biotech, or Pharmaceutical industries.
- Proven experience with labelling operations, artwork lifecycle management, change control, and remediation programs.
- Deep understanding of global labelling regulations and quality standards (FDA, EU MDR/IVDR, UDI, GMP, ISO).
- Experience supporting product lifecycle management (including IFUs, packaging artwork, translations, and market-specific requirements).
- Strong track record of leading cross-functional transformation initiatives and regulatory inspection readiness.
Knowledge, Skills & Abilities:
- Exceptional program management skills (scheduling, dashboards, business case development, and risk management).
- Familiarity with enterprise labelling systems, artwork management tools, and electronic document management systems (EDMS).
- Outstanding analytical, critical thinking, and problem-solving capabilities.
- Excellent written and verbal communication skills, with a demonstrated ability to present complex information clearly to senior leadership and regulatory stakeholders.
- Highly proficient with MS Office tools, including MS Project, Excel, and PowerPoint.
- Ability to travel 10-30% annually depending on business needs.
Please apply using the apply button today.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Quality and Regulatory Labelling Program Manager employer: Randstad Engineering
Join a dynamic and innovative team as a Quality and Regulatory Labelling Program Manager in Basingstoke, where you will play a crucial role in steering compliance initiatives for a global leader in the Life Sciences sector. Our company fosters a collaborative work culture that values diversity and promotes employee growth through continuous learning opportunities and cross-functional collaboration. With the flexibility of remote work and a commitment to operational excellence, we offer a rewarding environment for professionals seeking to make a meaningful impact in their field.
StudySmarter Expert Advice🤫
We think this is how you could land Quality and Regulatory Labelling Program Manager
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work in Quality and Regulatory roles. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global labelling regulations. Be ready to discuss how your experience aligns with the role's requirements, especially around compliance and risk management.
✨Tip Number 3
Showcase your project management skills! Use examples from your past experiences to demonstrate how you've successfully led complex programmes and managed cross-functional teams.
✨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 Quality and Regulatory Labelling Program Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality and Regulatory Labelling Program Manager role. Highlight your relevant experience in project management, compliance, and labelling operations. We want to see how your background aligns with our needs!
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. Share specific examples of your past achievements in managing complex programmes and how they relate to the responsibilities outlined in the job description.
Showcase Your Skills:Don’t forget to highlight your exceptional program management skills and familiarity with regulatory standards. We’re looking for someone who can clearly communicate complex information, so make sure your application reflects that!
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 all the amazing candidates like you!
How to prepare for a job interview at Randstad Engineering
✨Know Your Regulations
Brush up on global labelling regulations like FDA, EU MDR/IVDR, and ISO standards. Being able to discuss these in detail will show your expertise and readiness for the role.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed complex programmes in the past. Highlight your experience with scheduling, risk management, and cross-functional collaboration to demonstrate your leadership capabilities.
✨Be Ready for Scenario Questions
Expect questions about how you would handle specific challenges, such as labelling errors or regulatory changes. Think through potential scenarios and your strategies for addressing them to showcase your problem-solving skills.
✨Communicate Clearly and Confidently
Practice articulating complex information in a straightforward manner. This is crucial when discussing labelling initiatives with senior leadership and regulatory stakeholders, so make sure you can present your ideas clearly.
