
Regulatory Affairs Professional
1 week ago
We are seeking a highly skilled and experienced Regulatory Manager to join our team in the Asia Pacific region. This is an exciting opportunity for a professional with a strong background in regulatory affairs to contribute to the success of our organization.
- Key Responsibilities:
- Act as 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
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