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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
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