Regulatory Affairs Specialist (Chuyên Viên Đăng Ký Thuốc)

1. Set up plans for yearly regulatory activities.
2. Co-operate with Porfolio Department, RA Department in Poland to prepare a pipeline of 5 years for new products.
3. Collect and complete dossier of product according to regulations of DAV.
4. Prepare application and submit dossier of products, Submit of application for renewal on base of actual re-registration plan of company...
5. Make and remain a good relationship with DAV, perceive the related procedures at DAV in order to achieve the target for regulatory affairs activities.
6. Co-operate with RA and the related departments (QA, QC, R&D) in Poland to prepare documentation for registration, import license and other RA activities. All the documents for each project are ordered, checked, adjusted by RA Vietnam according to the established timeline and DAV regulations.
7. In contact with DAV weekly in order to control all the projects in Vietnam based on the established timeline to gain Marketing authorizations for medicinal products, certificates for food supplements.
8. Receive new regulations from DAV in time in order to adjust our whole activities accordingly.
9. Responsibility of pharmacovigilance activities.
10. Other supportive activities: order, check, provide technical documents to distributors, importers for regular activities such as tender, import, DAV's post marketing inspection.
11. On time reports and presentation about actual registration status.
Start working from 1st Feb 2021.