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Senior Manager, Regulatory Labelling Compliance
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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.
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Job Requirements
- Bachelor's degree in a scientific discipline required; MSc, PhD, or PharmD 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.
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Contact
To learn more, apply to this job post. To contact Amit directly, email him at amit.uma@meetlifesciences.com.
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