Regulatory Affairs Manager

Regulatory Manager, APAC

Job Description:

We are looking for a Regulatory Manager to ensure that our products meet all local and international health regulations. You will handle product approvals, prepare documents for health authorities, and make sure our labeling and marketing follow legal rules.

Regulatory Affairs

1. Main liaison personnel with Head Quarters and all Partners on Regulatory matters for APAC HQ's countries, not limited to Singapore, Malaysia, Indonesia, Philippines, Thailand, Vietnam, Australia & New Zealand.
2. Coordinate all queries, variations, submissions and registrations.
3. Handles product issues or complaints as well as quality issues.
4. Update of PDM (Product Data Management) records and Packaging records.
5. Maintain past dossiers and attend to queries relating to approved dossiers and dossier information.
6. Records of trademarks for SPAP countries.
7. Maintenance of GTIN (Global Trade Item Number) information for products marketed in SPAP countries.

Pharmacovigilance

1. Individual Case Safety Report (ICSR) monitoring, reporting & documentation for SPAP products marketed in Singapore.
2. Recall procedures, execution & documentation for SPAP products marketed in Singapore.
3. Coordination of recall procedures, execution & documentation for SPAP products marketed in SPAP countries in accordance to local regulatory requirements.
4. Quarterly reporting of weekly literature screening outcomes.
5. Annual reconciliation of ICSRs (Individual Case Safety Report) for Singapore.
6. Coordinate with SPAP partners to reconcile the ICSRs for their respective countries.
7. Pharmacovigilance training.
8. Main Local Safety Officer (LSO) in liaison with EU HQ.
9. Submission of Product Quality Reports (PQRs) and Periodic Safety Update Reports in countries where it is legally required.

To submit your application, please apply to this advertisement online or email your resume to [Confidential Information]. We regret to inform you that only shortlisted candidates will be notified.

EA License No.: 19C9807

Registration No.: R1982385 (Guo Yuwenxi)