Regulatory Affairs & QA Specialist (Singapore/Malaysia)

PASONA SINGAPORE PTE. LTD.; Singapore; On-site; SGD 46,000 - 55,000; Full time

Job summary

PASONA SINGAPORE PTE. LTD. in Clarke Quay, Singapore, seeks a Regulatory Affairs professional to manage Singapore and Malaysia regulatory lifecycle, ensuring timely approvals and continuity of product supply.

The role also covers Quality Assurance duties, including GDP compliance and liaising with health authorities, with opportunities to mentor junior staff and contribute to continuous improvement.

Qualifications

• Regulatory lifecycle management for Singapore and Malaysia.
• Prepare and submit registration dossiers for approvals.
• Manage variations, renewals, and post-approval commitments.
• Review labelling and artwork for compliance.
• Track submissions and maintain regulatory records.
• Liaise with HSA, NPRA and other authorities.

Responsibilities

• Regulatory lifecycle management for Singapore and Malaysia.
• Prepare and submit registration dossiers for approvals.
• Manage variations, renewals and post-approval commitments.
• Review product labelling and packaging for compliance.
• Track submissions and maintain regulatory documentation.
• Coordinate with cross-functional teams for launches and supply.
• Oversee GDP quality activities and product disposition (if appointed).
• Support inspections and audits by health authorities.
• Review promotional materials for regulatory alignment.
• Collaborate with regional and global teams to ensure timely regulatory actions.

Job description

PASONA SINGAPORE PTE. LTD. in Clarke Quay, Singapore, seeks a Regulatory Affairs professional to manage Singapore and Malaysia regulatory lifecycle, ensuring timely approvals and continuity of product supply.

The role also covers Quality Assurance duties, including GDP compliance and liaising with health authorities, with opportunities to mentor junior staff and contribute to continuous improvement.