药品注册主管

Job Description :
1. Report to: RA Manager
2. Responsible for communication with India RA team about current NMPA/CDE regulations and guidelines.
3. Responsible for collection of the required technical dossiers from India RA team of import drugs (Dosage formulation)
for new IDL filing, IDL renewal filing, variation filing, and responses to CDE query, etc
4. Responsible for preparation of module 2 and overview information (dossier No. 1-8).
5. Responsible for translation(English to Chinese ),Finalization and submission of the registration dossiers of import drugs (Dosage formulation and API ) for new IDL filing, IDL renewal filing, variation filing, responses to CDE query and coastal testing, etc.
6. Responsible for communication with the authorities including but not limit to NMPA, CDE, NIFDC, port IDC, etc, to ensure smooth of the registration/coastal testing progress.
7. Finish the other RA related jobs assigned by RA head.
Position qualifications:
1. Degree in Scientific/Biochemistry/Pharmacy
2. At least5 years'working experience in regulatory affairs, especially for the registration experience of biologic drugs is preferred.
3. Familiar with the 《National Regulation of Drug Registration》 and latest 《Drug administration laws and regulations》
4. Familiar with various guiding principles as well as local/regional regulatory processes and changes that are implemented or being considered.
5. Direct experience for new IDL filing, IDL renewal filing, variation filing.
6. Fluent spoken and written English.