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[담당업무] *Product registration & Maintenance of existing product licenses
• amendment of licenses and Product registration
• Documentation update for registration information (Update for; Registration master file, SharePoint master file, Distribution registration folder, PMF/LLL update, etc.)
• Communicate and align with the global regulatory team to get support for local product registration and manage local regulatory systems and processes
• Provide product registration status and results to the business team and related parties to help their plan and preparation in advance, work collaboratively with the business team, and identify and seek resolution of registration and quality issues for the operational effectiveness
*Compliance with MFDS & Corporate QA requirements
• KGMP maintenance
• Prepare/revise/control QM, PD, and SOP to ensure compliance with the Corporate and the MFDS requirements for Korean operation
• Track and follow up on the requirements/new regulation
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