Description of Job Duty:
1. Report to: RA Manager
2. Responsible for collection of the required technical dossiers from India RA team for new IDL filing, IDL renewal filing, variation filing, and responses to CDE query, etc.
3. Responsible for translation (English to Chinese), finalization and submission of the registration dossiers for new IDL filing, IDL renewal filing, variation filing, responses to CDE query and coastal testing, etc.
4. Responsible for preparation of module 2 and overview information (dossier No.1-8)
5. Responsible for communication with India RA team about current CFDA/CDE regulations and guidelines.
6. Responsible for communication with the authorities including but not limit to CFDA, CDE, NIFDC, port IDC, etc, so as to smooth the registration/coastal testing progress.
7. Finish the other RA related
任职要求:
1. 本科或本科以上药学相关专业毕业;具有良好的英语阅读翻译和写作能力。
2. 工作积极主动细心,服从领导的安排。
3. 性格开朗,能融入团队工作。
4. 接受应届毕业生。
上海市徐汇区海市徐汇区中山西路1800号兆丰环球大厦