Asia Pacific Regulatory Affairs Specialist

1 week ago

Singapore beBeeRegulatory Full time $90,000 - $120,000
Regulatory Manager Job Description">

As a key member of our team, the Regulatory Manager, Asia Pacific will serve as the primary liaison with Head Quarters and all Partners on Regulatory matters for Asia Pacific countries. This role is responsible for coordinating all queries, variations, submissions and registrations.

  • Handling product issues or complaints as well as quality issues.
  • Update of PDM (Product Data Management) records and Packaging records.
  • Maintenance of past dossiers and attending 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.

Required Skills and Qualifications:

  • 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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