Duties:
- End-to-end registration activities (pre- and post-approval, withdrawal) for Hong Kong and Macau markets for PharmaMedical Device.
- Ensure new product submissions are filed with necessary documentation in timely manner
- Liaise with Health Authority to ensure the product registrations 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
- 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 hocrequests, e.g. regulatory information relevant to mitigating supply issue, or named-patient supply
Requirements:
- 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.
