Regulatory Manager, Asia Pacific

Borr Drilling; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading company is seeking a Main Local Safety Officer for regulatory affairs in the Asia Pacific region. The role involves coordinating with HQ and partners on safety and compliance matters, managing product quality documentation, and ensuring adherence to local regulations. Candidates should possess a relevant degree and 3-5 years of related experience in the pharmaceutical field.

Qualifications

• 3-5 years of experience in regulatory affairs, preferably with herbal or pharmaceutical products.
• Good understanding of regional health regulations.

Responsibilities

• Main liaison for regulatory matters in Asia Pacific countries.
• Coordinate queries and regulatory submissions.
• Handle product quality and safety reports.

Skills

Attention to Detail

Organizational Skills

Education

Degree in Pharmacy, Biology, Chemistry, or related field

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.