Job Description
Write & review regulatory submissions like IND, IMPD, MAA, NDA, DMF and documents for regulatory advices.
Guidance to cross functional teams on regulatory expectations for US, EU, Japan and major markets.
Ensuring regulatory compliance in cross functional teams and managing cross functional team deliverables.\
Review of CMC, clinical, bioanalytical development related documents & ensure compliance to CTD requirements
Guidance to cross functional teams on regulatory expectations for US, EU, Japan and major markets.
Ensuring regulatory compliance in cross functional teams and managing cross functional team deliverables.\
Review of CMC, clinical, bioanalytical development related documents & ensure compliance to CTD requirements
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