Assistant Regulatory Affairs & Quality Assurance

About the role

The Assistant Regulatory Affairs & Quality Assurance professional will support the registration, approval and lifecycle maintenance of pharmaceutical products for the Hong Kong market. The role works closely with global manufacturers, internal teams and the Hong Kong Department of Health to ensure compliance and timely product launches.

Key responsibilities

• Prepare, compile and submit registration dossiers to the Hong Kong Department of Health.
• Review technical, clinical and quality documentation, including COAs, stability data and analytical comparability reports.
• Maintain up‑to‑date knowledge of local regulations, monitor changes and communicate updates internally.
• Manage communications with the Department of Health, respond to deficiency letters and attend regulatory briefings.
• Ensure bilingual labeling (English and Traditional Chinese) meets Hong Kong standards.
• Oversee tender bidding, HA & DH product listing and prepare related documents.
• Support regulatory strategy for new product launches, renewals and post‑approval changes.
• Investigate product complaints, conduct risk assessments (FMEA) and initiate change controls.
• Organise mock recalls and contribute to pharmacovigilance activities.
• Maintain accurate records of submissions, approvals and post‑approval commitments, and draft Hong Kong‑specific SOPs.

Required profile

• 3–5 years of hands‑on regulatory affairs experience in the pharmaceutical or biopharmaceutical industry.
• Strong understanding of Hong Kong regulatory requirements and dossier preparation.
• Excellent written and verbal communication in English; fluency in Cantonese is essential, Mandarin a plus.
• Proven project‑management and coordination skills with external partners, contract manufacturers and CROs.
• Experience in team leadership and ability to manage multiple projects in a deadline‑driven environment.

Required skills

• Regulatory dossier preparation and submission to the Hong Kong Department of Health.
• Risk assessment methodologies, including Failure Mode Effects Analysis (FMEA).
• Pharmacovigilance and product complaint investigation.
• Tender bidding and HA/DH product listing processes.
• Change control management and SOP development.