JOB SUMMARY:
Establish and strengthen site regulatory expertise & capability to support biological drug substance and drug product CDMO business.
Provide expertise in NMPA’s IND/BLA submission pathway and regulatory requirements for biological products at various developmental & commercial stages in supporting the creation of CTD M3-Quality/CMC business proposals and Clients in their submissions’ journey.
Liaise with global regulatory experts to address Clients’ ambition to submit IND/BLA primarily in China and also in other main jurisdictions (USA, EU).
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