Quality and Regulatory Affairs Specialist

About the role

We are looking for a Quality and Regulatory Affairs (QRA) Specialist to join our Singapore headquarters. The role will support the full quality management system and regulatory lifecycle of our pharmaceutical products, ensuring compliance with local and international standards. You will work closely with cross‑functional teams to maintain product quality and safety across the region.

Key responsibilities

• Implement and maintain the company’s Quality Management System (QMS).
• Manage QRA‑related inspections, licences and compliance activities.
• Oversee supplier qualification, monitoring and performance.
• Conduct investigations of deviations, non‑conformities, CAPA and customer complaints.
• Review technical documentation and perform basic investigations.
• Lead drug safety detection activities and support pharmacovigilance processes.
• Deliver internal training to ensure regulatory and quality compliance.
• Prepare pre‑market regulatory submissions for commercial distribution.
• Maintain all QRA documentation and records in accordance with GxP requirements.
• Support ad‑hoc cross‑functional projects as needed.

Required profile

• Degree in Engineering, Life Sciences, Pharmacy or a related discipline.
• Experience with Quality & Regulatory Affairs activities such as QMS, SOP development and inspection readiness.
• Familiarity with GDPMDS, GDP, regulatory inspections and compliance.
• Strong documentation, problem‑solving and communication skills.
• Experience in regional QRA roles, distribution companies or fast‑growing environments is a plus.

Required skills

• Quality Management System (QMS) implementation
• Standard Operating Procedure (SOP) development
• CAPA and deviation investigation
• Supplier management
• Regulatory submission preparation
• GDPMDS and GDP knowledge
• Pharmacovigilance and drug safety detection
• Document control and GxP record keeping