Responsible for management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. To work closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings.
https://www.indeed.com/viewjob?t=regulatory+affairs+associate+cmc&jk=dd0e844b838c6d33&_ga=2.14934518.1969368399.1543686974-1024118673.1543686974
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