The Asst. Regulatory Affairs & Quality Assurance will play a key role in managing all regulatory activities related to the registration, approval, and lifecycle maintenance of products in the Hong Kong market. This position requires close collaboration with global manufacturers, internal cross-functional teams, and regulatory authorities to ensure compliance with evolving regulatory requirements and timely product approvals.

Key Responsibilities:

· Lead the preparation, compilation, and submission of registration dossiers to the Hong Kong Department of Health.

· Conduct in-depth reviews of technical, clinical, and quality documentation provided by manufacturers.

· Ensure all dossiers meet current regulatory guidelines, standards, and local requirements.

· Collaborate with manufacturing partners to gather accurate and complete regulatory documentation.

· Review and align product information, Certificates of Analysis (COAs), stability data, and analytical comparability reports.

· Interpret and implement the latest local regulations and guidance documents.

· Monitor regulatory changes and provide internal updates to ensure continued compliance.

· Manage direct communication with the Department of Health and respond to deficiency letters or inquiries in a timely manner.

· Attend briefings, stakeholder consultations, and training sessions hosted by regulatory authorities.

· Ensure local labeling compliance including accurate bilingual (English + Traditional Chinese) translations and format alignment with Hong Kong’s regulatory standards.

· Maintain up-to-date knowledge of interchangeability and pharmacovigilance requirements.

· Oversee HA & DH tender bidding and product listing at different stages.

· Prepared and evaluated HA&DH tender documents and CIP Managed actions in response to DSC enquiries.

· Support regulatory strategy development for new product launches and variations (e.g. renewals, line extensions, post-approval changes).

· Contribute to the creation of submission plans, timelines, and risk assessments.

· Investigate product complaints and prepared reports

· Initiate change controls and applied risk assessment models.

· Organize mock recalls and involve in pharmacovigilance

· Maintain meticulous records of submissions, approvals, correspondences, and post-approval commitments.

· Draft and manage HongKong-specific SOPs related to regulatory filings and submissions.

Qualifications & Skills:

· 3–5 years of hands-on regulatory affairs experience in the pharmaceutical or biopharmaceutical industry.

· Sound understanding of Hong Kong’s regulatory requirement.

· Experience in preparing and submitting dossiers.

· Strong coordination skills with external partners, contract manufacturers, and CROs.

· Excellent written and verbal communication skills in English. Proficiency in Cantonese is essential; Mandarin is a plus.

· High attention to detail, problem-solving mindset, strong project management skills.

· Experience in team management and leadership skills.

· Ability to manage multiple projects and work in a dynamic, deadline-driven environment.

· Knowledge of biosimilar product registration is an added advantage.