Vietnam
Responsible for registering the medicines, cosmetics, food supplements and medical devices to Ministry Of Health Communicate with clients to prepare and finalize registration dossiers, supplement dossiers as well as variation dossiers. Update and advise regulations, and propose solutions to clients and relevant departments. Co-ordinate with QA and relevant departments to conduct sub-label redressing in case labels of shipments in DKSH warehouse do not comply with approved ones or Vietnam’s regulations. Support management for build-up SOPs for Regulatory Affairs Department.
Responsible for registering the medicine and cosmetic Ministry Of Health Communicate with clients to prepare and finalize registration dossiers, supplement dossiers as well as variation dossiers. Coordinate with manufacturers to maintain the product grid and update them on regulation. Review and approve artwork of label and package insert. Coordinate with marketing department to check up of brochures and support them to prepare tender documents for hospitals.
Responsible for researching and developing new products. Develop new products. Validate make- over products from parent company. Compose ACTD dossiers to register new products. Optimize manufacturing process for products.