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Regulatory Manager, Asia Pacific

Regulatory Manager, Asia Pacific

RN CARE PTE. LTD.Singapore
26 days ago
Job description

Job Description :

  • Main liaison personnel with Head Quarters and all Partners on Regulatory matters for Asia Pacific countries
  • Coordinate all queries, variations, submissions and registrations.
  • Handles product issues or complaints as well as quality issues.
  • Update of PDM (Product Data Management) records and Packaging records.
  • Maintain past dossiers and attend to queries relating to approved dossiers and dossier information.
  • Records of trademarks for APAC countries.
  • Maintenance of GTIN (Global Trade Item Number) information for products marketed in APAC countries.
  • Individual Case Safety Report (ICSR) monitoring, reporting & documentation for products marketed in Singapore.
  • Recall procedures, execution & documentation for products marketed in Singapore.
  • Coordination of recall procedures, execution & documentation for products marketed in APAC countries in accordance to local regulatory requirements.
  • Quarterly reporting of weekly literature screening outcomes.
  • Annual reconciliation of ICSRs (Individual Case Safety Report) for Singapore.
  • Coordinate with partners to reconcile the ICSRs for their respective countries.
  • Pharmacovigilance training.
  • Main Local Safety Officer (LSO) in liaison with Pharmacovigilance Department in HQ
  • Submission of Product Quality Reports (PQRs) and Periodic Safety Update Reports in countries where it is legally required.

Requirements :

  • Degree in Pharmacy, Biology, Chemistry, or a related field.
  • 3-5 years of experience in regulatory affairs, preferably in herbal or pharmaceutical products.
  • Good understanding of regional health regulations.
  • Strong attention to detail and organizational skills.
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    Manager Asia Pacific • Singapore