Role: - Carry out all necessary work to ensure the efficient and timely submission for API/Excipient and IVD/medical device products application, including new registration/ supplementary/ change application/ annual report etc. Coordinate with global/regional regulatory counterpart to collect information required during the process. - Maintenance the specific registration management system. - Monitor regulation development and participants in local association activity if necessary. - Support local business on daily basis request. - Other relevant works to support the team. e.g. support on ChP project, sample management, Regulatory intelligence project and so on.
Job-specific Competencies & Skills: - Good communication with multi-departments - Favorable organizational and time management skills. - Ability to work in multi-cultural teams. - Proficient in MS Office Software (word, Excel, PowerPoint etc) - Proactive attitude towards work
Background： - Bachelor’s or graduate degree in pharmaceutical related major - 10 years relevant experience in Regulatory affairs is preferred - Fluent in spoken and written English - Good understanding in regulatory operations area
