Responsible for the management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. Involves working 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. Expertise with biologics and/or drug/biologic/device products is strongly preferred.
https://www.indeed.com/viewjob?t=regulatory+affairs+associate+cmc&jk=bc3b7f840cbc32a8&_ga=2.70862547.2109980052.1549661589-2077807285.1533320279
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