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.
Job Requirement
Requirements
Can work at least 24 hours per week for a duration of 4 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 languages 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.
