岗位描述(节选)
The job role is responsible for CMC dossiers related planning,coordinating, management, reviewing and finalization, including but not limited to IND submission, CMC amendment and BLA fast approval.
DSUR CMC dossiers review and preparation.
Support the QC testing, registration and GMP inspection, MAH manufacture license.
Follow up and solve the CMC queries from Health Authority (NMPA, FDA, etc.).
C……
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