Regulatory Manager, Asia Pacific
RN CARE PTE. LTD.
Job Description:
Requirements:
- 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.
JOB SUMMARY
Regulatory Manager, Asia Pacific
RN CARE PTE. LTD.
Singapore
2 days ago
N/A
Full-time
Regulatory Manager, Asia Pacific