Regulatory Affairs/Associate(法規組專員)

1. Prepare submission dossiers for the application of clinical trial for drugs/medical devices, including study protocols, queries, amendments, annual reports and closure
2. Develop/review informed consent form
3. Translation of dossier contents (when applicable) form English to Chinese, and vice versa
4. Progress management for dossiers submitted, and manages submission dossiers
5. Regulatory affairs consultation