Senior Regulatory Affairs Associate- Labeling Strategy

من الإعلان الأصلي

India Accountabilities: Global Labeling Strategy and Documentation: Develop, maintain, and update global labeling documents, including Company Core Data Sheets (CCDS), United States Prescribing Information (USPI), and regional labels, ensuring alignment with requirements in the United States, European Union, Switzerland, Canada, Australia, and other markets. Regulatory Compliance and Lifecycle Management: Manage post-approval labeling activities, including artwork updates, safety variations, xEVMPD submissions, and Periodic Safety Update Reports (PSURs), in accordance with applicable…