Profile:
This role is responsible for ensuring Merck's compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics. Includes jobs which are not directly specialized in one of the other defined Regulatory Affairs job families or which are fully responsible for the whole functional area.

Role:
83 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.
83 Maintenance the specific registration management system.
83 Monitor regulation development and participants in local association activity if necessary.
83 Support local business on daily basis request.
83 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:
83 Good communication with multi-departments
83 Favorable organizational and time management skills.
83 Ability to work in multi-cultural teams.
83 Proficient in MS Office Software (word, Excel, PowerPoint etc)
83 Proactive attitude towards work

Background：
83 Bachelor’s or graduate degree in pharmaceutical related major
83 10 years relevant experience in Regulatory affairs is preferred
83 Fluent in spoken and written English
83 Good understanding in regulatory operations area