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Global Labeling Operations Manager
4 hours ago
Job Description
The Global Labeling Operations Lead will coordinate, manage, and execute activities related to the approval and maintenance of printed labeling components. This includes packaging mock-ups, patient information leaflets, and container labeling. The role will also support the Global Labeling and Regulatory Strategy teams with various operational labeling activities.
This position is within Global Regulatory Affairs (GRA) and reports to the Head of Global Labeling.
Main Responsibilities
- Manage labeling and packaging artwork projects affecting multiple products to ensure timely delivery.
- Coordinate labeling artwork lifecycle management in collaboration with the Regulatory Strategy Leads and Labeling Operations Coordinators.
- Provide expertise to cross-functional teams and external vendors regarding regulatory requirements for the development of printed labeling components.
- Review and approve mock-ups and artworks to ensure compliance and timely delivery of print-ready packaging and labeling documents.
- Coordinate EU labeling readability testing and translation activities with vendor and oversee affiliate review of EU SmPC translations during linguistic review.
- Manage EU SmPC master documents in the Veeva Regulatory Information Management (Veeva RIM) system during product labeling life cycle.
- Collaborate with Global Strategic Labeling Leads to support the delivery of submission-ready EU and US labeling documents.
- Serve as a liaison to external vendor regarding the creation, review and submission of US Structured Product Labeling (SPL) content.
- Support global labeling management improvement initiatives and participate in the development of SOPs, Work Instructions, and guidance documents.
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