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Job Description

• ACTD preparation for new drug product development, document preparation for post approval changes compliance with regulatory requirement.
• Coordinates and collects specific registration information with R&D, Manufacturing, Clinical and other applicable departments, as necessary to support registration requirements.
• Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met.
• Manage product registration, including change notification and renewal, for submission to regulatory authority and monitor the progress, status and timeline.
• Maintain product registration record to ensure proper documentation and record filing.
• Responsible to ensure that regulatory clearances are obtained in a timely manner in line with expected business plans and responds to potential submission deficiencies.
• Participate in other ad-hoc activities assigned.