Job Description

Description

Role description
Product registration & maintenance

  • Develop the regulatory strategy/plan for the earliest launch of new products on best conditions (indication, forms, minimum documents requirements etc) in Korea by sourcing necessary documents from HQ’s worldwide regulatory function.
  • Implement/manage products registration procedures required by Korean pharmaceutical regulation to achieve the earliest market entry.
  • Harmonize Korean products labels and promptly notice to GRA about local impositions for the labelling from the MFDS to avoid any local issue.
  • Update the safety information in line with the CDS and other reference countries.
  • Product lifecycle maintenance: Keep product license to be compliant with regulations.

    • Product QA

  • Package compliance: Secure the package compliance in line with the local regulation and AZ compliance.
  • Responsible for company’s compliance into all rel...

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