Global Labeling

Job Description / Role ProfileFunction: Global Labeling OperationsDepartment: Global Regulatory AffairsOBJECTIVES/PURPOSE:Responsible for leading Regional Labeling activities in supporting Local Operating Company (LOC) Regulatory Leads towards achievement of seamless execution of labeling processes and continuous process improvement.Partners with LOC Regulatory Leads to enhance labeling operational excellence and compliance at the LOC level.Drives standardization of implementation of Global Labeling processes and use of Global Labeling systems (MEDIVA RIM for Labeling) at the LOC level by providing proactive training, sharing best practices and guidance to LOC Regulatory Leads to achieve operational excellence and ensure compliance.Acts as a conduit between Global Labeling and LOC Regulatory Affairs, establishing a two-way communication channel to strengthen understanding of global processes, share challenges and provide support during audits/inspections.Supports LOC Regulatory Leads in the management of single country products by defining process and ways of working for the maintenance of the local product labeling in partnership with Global Labeling function.ACCOUNTABILITIES:• Management of local product labeling lifecycleProvides guidance to LOC Regulatory Leads on the management of local labeling exceptions.Proactively supports LOC Regulatory Leads to ensure correct market label dependencies are accurately reflected in Labeling systems.Oversight of local labeling safety variations submissions; ensures that any deferral requests are submitted/approved on time and with adequate justification and overall on time submission of local labeling safety variations.Supports LOC Regulatory Leads with labeling related Quality Events (Deviations), providing guidance on good investigation practices, sharing best practices across LOCs and ensures a standardized approach to CAPAs and Effectiveness Checks as required.• Global Labeling

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