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. Expertise with biologics and/or drug/biologic/device products is strongly preferred. Responsible for obtaining and interpreting CMC regulations and guidance and providing regulatory advice to technical operations departments.
https://www.indeed.com/viewjob?t=regulatory+affairs+associate+cmc&jk=642e0da0221b7233&_ga=2.32965694.1646275761.1543763749-1408033885.1530798869
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