• End-to-end registration activities (pre- and post-approval, withdrawal) for Hong Kong and Macau markets for Pharmaceutical, Medical Device and Food Supplement
• Ensure new product submissions are filed with necessary documentation in timely manner
• Liaise with Health Authority to ensure the production application can be approved within reasonable timeframe to support business plan
• Ensure the internal systems, records and relevant processes are observed and up-to-date
• Utilize different IT system to support daily RA operation such as new labeling development and manage RA projects.
• Participating in cross-functional projects and input regulatory assessment.
• Develop new label as per regulatory requirement and deploy the implementation plan with commercial and other functions.
• Maintain the company record and SOP to maintain the wholesale dealer license
• Keep abreast of regulatory environment and update relevant stakeholders to minimize the potential risk
• Promotional Material review to ensure regulatory compliance
• Support Taiwan in label development
• Provide regulatory support to business activities e.g. Hospital tenders and quotations
• Apply different license as per business needs e.g. ISMEM
• Participate in APAC regional projects to improve RA team operation efficiency and effectiveness
• Close co-operation with QA on ad hoc issue e.g. product release, or field corrective action
• Provide support for other ad hoc requests, e.g. regulatory information relevant to mitigating supply issue, or named-patient supply

• University graduate in biological science
• Minimum 2-3 years’ experience in regulatory affairs (or Quality Assurance) in pharmaceutical or medical device company
• Fluent in English and Cantonese

Interested parties please email a MS Word version resume and expected salary to [email protected] (cc:  [email protected]) and quote the job reference no.