RIO Execution Hub Manager - Philippines - Makati City
6 oras ang nakalipas
Job summary
Assist in the preparation, publication, tracking, and quality control of regulatory submissions ensuring compliance with document management standards Coordinate activities related to enterprise-wide regulatory management systems and provide guidance on moderately complex projects Apply skills and discipline knowledge to contribute to departmental work making decisions to resolve moderately complex problems and developing new options Work independently on assignments seeking directional review for unusual or complex problems and review the work of colleagues in a mentor role Guide operational teams in managing projects preparing resource forecasts and identifying areas for improvement in products processes or services Act as a point person for regulatory agency interactions including preparation of briefing packages strategy for meetings inspections responses to agency letters Understand challenge scientific arguments identify regulatory scientific data needs solve regulatory issues influence development new global products improvements existing products Manage registrations existing customer products compliance applicable regulations support global team efforts ensure high-quality compliant submissions Provide daily regulatory support Global Product Development teams lead logistics involved with clinical trial application CTA submissions Manage preparation registration packages responses deficiency letters suggest system improvements reduce cycle time increase efficiency
Paglalarawan ng trabaho
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