Qualification : Post graduation in Chemistry back ground.
Location : Beijing
Department: API Regulatory Affairs
Job responsibility:
1.Responsble for DMF Registration/samples submission/Deficiency handling/Amendments to CDE/NIFDC.
2.Should know the requirements of CDE and NIFDC Authorities.
3.Experience in Handling CDE and NIFDC queries .
4.Need to have knowledge in QC /QA activities to understand the requirements of CDMF.
5.Required minimum English communication skills to explain the concerns of CDE/NIFDC/PIFDC exactly to India RA team and to revert our solutions to Authorities.
Job Requirements:
1. Bachelor degree or above in pharmacy, biology, Chemistry, etc
2. At least 8-10 years of work experience (3 years in the registration department, the rest can be in the technical department (QA, QC and R&D department)
3. Extensive experience in API application (e.g. in China or US/EU market)
4. Fluent in spoken English, able to use English as the working language. Special excellence can relax the language requirements.