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MSDPosted 2 months ago
EXPIRED

Sr. Specialist, System Process & Regulatory Innovation

On-sitePetaling Jaya, Selangor, Malaysia

Full TimeSenior LevelEnterprise

Job Summary

Senior Specialist, Regional System Process & Regulatory Innovation within the GRACS organization, responsible for the end-to-end execution and support of regulatory systems, processes, and digital initiatives across the APAC region. Works with RIIM, BSOs, and regional stakeholders to deliver system-related activities, contribute to governance and strategic inputs, and maintain data quality and compliance within governance structures. Activities include end-user support, data-entry/adherence, training material creation, process optimization, system implementations and changes, testing/validation, and participation in regional governance forums to align with global and regional priorities.

Required Qualifications

  • Bachelor’s degree in Science, Information Technology, Pharmacy, or related discipline
  • Minimum 3 years of experience in Regulatory Affairs or Regulatory Operations system/process-related roles
  • Experience with regulatory systems and digital initiatives
  • Knowledge of regulatory business processes including submission planning and execution
  • Experience in system implementation, testing and validation, and user support
  • Ability to manage multiple tasks in a matrix environment
  • Strong communication and collaboration skills with regional stakeholders

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