· Oversight of regulatory submissions for assigned projects/countries, which may include completion of submissions or notifications, as required.
· Ability to read and understand regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
· Investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.
· Other duties as assigned.
· Can work at least 24 hours per week for a duration of 4 months to 6 months.
· Fresh graduates for senior students in related majors, such as biomedical engineering, biotechnology, and medicinal chemistry.
· Fluent in English is a must, in other language will be an advantage. Candidates who can speak Chinese will be a big plus.
· Ability to manage multiple projects, set priorities to meet deadlines.
· Keeping attention to details.
· Strong interpersonal skills, in written and oral.
· Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.
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