Regulatory Affairs Coordinator Lead
13 hours ago
Key Responsibilities
The Global Labeling Operations Lead is responsible for coordinating and managing activities related to the approval and maintenance of printed labeling components. This includes:
- Managing labeling and packaging artwork projects affecting multiple products to ensure timely delivery.
- Coordinating labeling artwork lifecycle management in collaboration with the Regulatory Strategy Leads and Labeling Operations Coordinators.
- Providing expertise to cross-functional teams and external vendors regarding regulatory requirements for the development of printed labeling components.
- Reviewing and approving mock-ups and artworks to ensure compliance and timely delivery of print-ready packaging and labeling documents.
Qualifications
The ideal candidate has 5+ years of experience in Labeling Operations within the pharmaceutical industry. Experience in developing regulatory content for printed labeling components for EU and/or US submissions is required. Strong knowledge of EU and/or US labeling regulations and guidance is essential. Fluency in English is required, with additional language skills a plus.
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