At a Glance
- Tasks: Lead global regulatory labelling compliance and ensure high standards in patient safety.
- Company: Join a global biopharmaceutical leader dedicated to innovative therapies.
- Benefits: Remote work flexibility, competitive salary, and opportunities for professional growth.
- Other info: Collaborative international environment with a focus on continuous improvement.
- Why this job: Make a real impact on patient outcomes while driving operational excellence.
- Qualifications: Bachelor's degree in science; 3-5 years in regulatory affairs or global labelling.
The predicted salary is between 63000 - 77000 £ per year.
- Senior Manager, Regulatory Labelling Compliance
- Full-time, permanent role
- Remote - can be based in the UK or Germany
Join a global biopharmaceutical organization committed to delivering innovative therapies that improve patient outcomes worldwide. As the
Senior Manager, Regulatory Labeling Compliance , you will play a critical role in ensuring global labeling activities meet regulatory requirements while maintaining the highest standards of compliance, quality, and patient safety.
Working cross-functionally with Regulatory Affairs, Pharmacovigilance, Quality, Supply Chain, and Technical Operations, you will oversee global labeling processes, compliance metrics, audit readiness, and continuous process improvements.
This is an excellent opportunity for a regulatory professional who thrives in a collaborative, international environment and enjoys driving operational excellence across complex global labeling programs.
Duties
- Oversee the global distribution, tracking, reporting, and implementation of approved product labeling changes while ensuring compliance with global regulatory requirements.
- Serve as the subject matter expert for Regulatory Information Management Systems (RIMS) and other labeling tracking systems, maintaining accurate documentation and supporting end-to-end labeling processes.
- Monitor labeling compliance metrics, develop dashboards and reports, identify quality events, conduct root cause analyses, and implement effective CAPA plans to support continuous improvement.
- Support regulatory inspections and audits by maintaining audit-ready documentation, contributing to inspection activities, and ensuring compliance with global labeling policies and Pharmacovigilance requirements.
- Collaborate with cross-functional global stakeholders to manage labeling projects, represent Global Labeling on product teams, support system enhancements, and drive process optimization initiatives.
- Job Requirements
- Bachelor's degree in a scientific discipline required; MSc, Ph D, or Pharm D preferred, with 3-5 years of pharmaceutical regulatory affairs or global labeling experience.
- Strong understanding of global labeling regulations, labeling compliance, regulatory inspections, audits, and end-to-end labeling processes within the pharmaceutical industry.
- Experience using Regulatory Information Management Systems (RIMS), electronic document management systems (EDMS), or other global labeling tracking platforms.
- Excellent analytical, organizational, and communication skills, with the ability to manage multiple projects, simplify complex regulatory information, and collaborate effectively across global cross-functional teams.
- Demonstrated problem-solving ability, strong attention to detail, and a proactive approach to identifying risks, driving process improvements, and maintaining compliance in a dynamic global environment.
- Contact
To learn more, apply to this job post. To contact Amit directly, email him at .
Senior Manager, Regulatory Labelling Compliance in Stevenage employer: Meet Life Sciences
As a Market Access Consultant with our client, you will be part of a dynamic team that values innovation and collaboration in the evolving healthcare landscape. The company offers a supportive work culture with opportunities for professional growth, including mentoring junior team members and leading impactful projects. With competitive compensation, hybrid working options, and comprehensive benefits, this role provides a meaningful opportunity to contribute to the expansion of European Value & Access capabilities while enjoying a fulfilling work-life balance.
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We think you need these skills to ace Senior Manager, Regulatory Labelling Compliance in Stevenage
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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 Meet Life Sciences that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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