Coordinator Regulatory Submission isresponsible for providing support and assistance, under the direction of senior staff, in the compilation and maintenance of clinical trials and other regulatory applications to regulatory authorities in Taiwan and Hong Kong.
- Under the direction of senior staff, assist with the formatting and compilation of regulatory submissions dossiers and import permit applications
- Provide support assistance to senior staff in the upkeep of regulatory authority submission, correspondences and filing /archiving
- Perform document acceptability checks of submission components.
- Update status reports and tracking sheets of ongoing and pending regulatory projects with input provided by senior staff.
- Organise shipping of documentation to clients, regulatory authorities and within Covance.
- Perform other activities related to regulatory submissions function as required by management.
Bachelor’s Degree in Life Sciences or equivalent
♦ Excellent verbal and written communication skills.
♦ Computer literacy in basic functions (Word, Excel)
♦ Good planning and organizational skills; detail oriented.
♦ Flexibility, ability to switch back and forth between multiple projects/tasks.
Entry Level (0-1 year Experience in regulatory or drug development)
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