Global Regulatory Affairs Leader

Gateway Search Pte Ltd; Singapore; Vor Ort; SGD 90.000 - 130.000; Vollzeit

Zusammenfassung

Gateway Search Pte Ltd is seeking a Regulatory Manager in Singapore to ensure products meet local and international health regulations. You will oversee approvals, prepare documentation for health authorities, and ensure labeling and marketing comply with legal rules.

You will serve as the main liaison with HQ and APAC partners, coordinating queries, variations, submissions and registrations, while handling product issues and maintaining regulatory records.

Qualifikationen

• Experience handling regulatory submissions and health authority documents.
• Ability to ensure labeling and marketing comply with applicable laws.
• Strong coordination with HQ and partners across APAC.
• Pharmacovigilance training and ICSR awareness preferred.

Aufgaben

• Main liaison with HQ and Partners on Regulatory matters for APAC countries.
• Coordinate all queries, variations, submissions and registrations.
• Handle product issues, complaints, and quality issues as they arise.
• Maintain Product Data Management (PDM) records and packaging records.
• Manage dossiers, trademarks, and GTIN information for SPAP markets.
• Monitor ICSR, reporting, and documentation for SPAP products in Singapore.

Kenntnisse

Regulatory affairs

APAC coordination

Pharmacovigilance

Documentation management

Quality & compliance

Jobbeschreibung

Gateway Search Pte Ltd is seeking a Regulatory Manager in Singapore to ensure products meet local and international health regulations. You will oversee approvals, prepare documentation for health authorities, and ensure labeling and marketing comply with legal rules.

You will serve as the main liaison with HQ and APAC partners, coordinating queries, variations, submissions and registrations, while handling product issues and maintaining regulatory records.