1.Execution of overseas registration for delegated market
Assist / Responsible for collection and preparation on relative data, file writing, CTD dossier forming and revising to conform to the overseas registration requirements for market access.
2.Project management on overseas submission
1）Assist project management on overseas submission in delegated country, including international cooperation initiative, documents completed and dossier applications, review and approval of tracking per the planning registration timeline and each milestone.
2）Responsible for planning, organization, coordination and management some offshoot project, which may be required in the process of the registration project progress in specified country, such as overseas official GMP inspection, animal experiments, overseas clinical trials, etc.
3. Internal and external coordination on projects
Responsible for effective communication and coordination with internal functions, including the plant, R&D department to ensure the quality of registration data provided from related departments and the workable timeline for submission.
Responsible for communicating with external partners to ensure overseas registration progress smoothly, following up the official review progress, timely to seek resource to solve the problems if defects found and prompt to provide the solutions to senior management.
4. Document management and maintenance
Orderly management of international common documents for overseas registration of company products and regularly updated in aspects on Quality, Non-clinical, Clinical parts.
5.Complete other tasks assigned by superior Supervisor
1.University degree or above in science aspect, preferably pharmaceutical English, pharmaceutical regulations, pharmaceutical management, pharmacology, clinical pharmacy, medicine science, or related field
2.Good command of Microsoft Word, Excel and PowerPoint
3.Good command of English
4.Good commuication and coordination capability