Expert - Regulatory Labelling operations
Expert - Regulatory Labelling operations
merck healthcare- Posted 26 days ago
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Job Description
Work Your Magic with us!
Ready to explore, break barriers, and discover more We know you've got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
Your Role
Apply now and become a part of our diverse team!
Ready to explore, break barriers, and discover more We know you've got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
Your Role
- The Global Labeling Excellence Lead is responsible for advancing operational excellence, process optimization, and continuous improvement across global labeling activities within Regulatory Quality Safety (RQS).
- This role partners closely with process owners and cross-functional stakeholders to assess, implement, and monitor efficient, compliant, and scalable labeling processes that support business priorities and regulatory expectations.
- As the successful GLE Lead, you will apply established continuous improvement and change-management methodologies to improve ways of working, strengthen documentation and tracking practices, and provide practical recommendations that enhance global labeling quality, compliance, and operational effectiveness.
- 8 – 12 Years of experience in Labeling Operations.
- End to End Labelling experience (EU/US)
- Strong project management skills, including stakeholder management and ability to demonstrate collaborative stakeholder engagement and influencing skills across a globally, matrix, cross-cultured environment.
- Operational excellence and continuous improvement mindset; experience contributing to cross-functional initiatives, process improvement efforts, or operational excellence projects.
- Support the development, maintenance, and review of documentation related to global labeling processes, including policies, standard operating procedures, work instructions, and supporting documents.
- Coordinate and track labeling document updates, internal milestones, and stakeholder inputs to support timely execution and alignment across global and regional teams.
- Develop and maintain global labeling project plans, submission timelines, and health authority interaction tracking to ensure commitments and deliverables are visible, current, and effectively
- managed.
- Establish and oversee a comprehensive global labeling commitment tracker to promote timely follow-through, accountability, and alignment with regulatory expectations and required timelines.
- Monitor implementation of new and updated labeling in markets, manage exceptions and deviations, and track compliance metrics to support on-time submissions and implementation.
- Partner with cross-functional RQS stakeholders on quality documentation, filing timelines, safety-related commitments, and related operational deliverables.
- Identify and implement process improvements, digital solutions, and new technologies that simplify work, improve labeling quality, and increase operational efficiency.
- Knowledge of global labeling regulations, regulatory submission processes, and health authority expectations.
- Experience supporting labeling governance, commitment tracking, market implementation, or compliance monitoring activities.
- Familiarity with change management, continuous improvement, process mapping, metrics, or operational performance tracking.
- Experience working in matrixed, global organizations and partnering with regulatory, safety, quality, medical, commercial, and regional stakeholders.
Apply now and become a part of our diverse team!
More Info
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Industry:
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Key Skills
Labeling Operations
Market Implementation
Labeling Governance
Regulatory Submission Processes
Commitment Tracking
