APAC Compliance Specialist

6 days ago

Singapore beBeeRegulatory Full time $90,000 - $120,000
Key Responsibilities

The primary role of the Regulatory Manager will be to act as a liaison between Head Quarters and all Partners on Regulatory matters for Asia Pacific countries.

  • Coordinate and manage queries, variations, submissions and registrations.
  • Handle product issues or complaints as well as quality concerns.
  • Maintain PDM (Product Data Management) records and Packaging records.
  • Ensure past dossiers are up-to-date and attend to queries relating to approved dossiers and dossier information.
  • Record trademarks for APAC countries.
  • Maintain GTIN (Global Trade Item Number) information for products marketed in APAC countries.
  • Monitor, report & document ICSR (Individual Case Safety Report) for products marketed in Singapore.
  • Implement recall procedures, execution & documentation for products marketed in Singapore.
  • Coordinate recall procedures, execution & documentation for products marketed in APAC countries in accordance to local regulatory requirements.
  • Report quarterly literature screening outcomes.
  • Anually reconcile ICSRs (Individual Case Safety Report) for Singapore.
  • Collaborate with partners to reconcile ICSRs for their respective countries.
  • Provide pharmacovigilance training.
  • Main Local Safety Officer (LSO) in liaison with Pharmacovigilance Department in HQ
  • Submit Product Quality Reports (PQRs) and Periodic Safety Update Reports where legally required.

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