Regulatory Affairs Officer

4 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia Kalbe Malaysia Sdn Bhd Full time 60,000 - 80,000 per year
  • Prepare, compile, and submit product registration dossiers to NPRA for new products, renewals, and variations.
  • Ensure regulatory submissions comply with NPRA requirements, including ASEAN Common Technical Dossier (ACTD
  • Liaise with the NPRA and Drug Control Authority (DCA) for regulatory communications, responses to queries, and product approvals.
  • Maintain and update product registration status, licenses, and records in regulatory databases.
  • Coordinate with internal departments (R&D, QA/QC, marketing, supply chain) to gather necessary documentation.
  • Review and approve product labeling, packaging, promotional materials, and patient information leaflets in line with NPRA regulations.
  • Ensure timely renewals of licenses for registered products and premises.
  • Maintain good documentation practices and ensure audit  readiness

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