Regulatory Manager, Asia Pacific

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.