Manage end-to-end regulatory submissions — including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), amendments, safety reports, Development Safety Update Reports (DSURs), and annual reports — in full compliance with applicable regulations.
Translate regulatory requirements into practical, workable submission plans; develop and maintain submission timelines; and coordinate internal and external authoring, review, comment adjudication, and finalization through to archival.
Deliver accurate and well-reasoned input during regulatory document reviews, ensuring alignment with current regulatory guidance and requirements.
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Adhere to Superior/Management’s directive, instruction, delegation and advices.
As and when required by the Management, to prepare report, presentation deck and any form of documents including presentation to the management, follow-up, updates and etc., all up to satisfactory of the Management.
To lead on special missions (administrative, Contract and Commercial related matters) as and when instructed by the Management.
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Lead and coordinate day-to-day customer service operations for the Robotics business, ensuring exceptional service delivery and customer satisfaction.
Act as the primary point of contact for customers, managing orders, quotations, service requests, inquiries, and escalations in a timely and professional manner.
Collaborate closely with Sales, Service, Supply Chain, and Finance teams to ensure seamless order fulfilment, issue resolution, and an outstanding end-to-end customer experience.
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Monitor Data Quality Dashboard results, perform root cause analysis, coordinate corrective actions and lead data cleansing activities to drive sustainable improvement.
Identify gaps between local master data and HEINEKEN global standards, recommend process improvements and coordinate cross-functional remediation.
Establish and maintain business data ownership, clarify accountabilities, facilitate governance decisions and track risks, actions and escalations.
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