Senior Associate Regulatory Operations

VirtualVocations
Saint Paul, Minnesota, United States
Full-time
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A company is looking for a Senior Associate, Regulatory Operations.Key ResponsibilitiesManage regulatory submission publish deliverables and ensure operational activities are executed successfullyPublish and prepare submission documents to be submission ready, maintaining proficiency with eCTD publishing toolsPerform regulatory research, track filings in Veeva RIMS, and participate in the creation and review of department SOPs and checklistsRequired QualificationsBachelor's degree in life science, physical science, or a closely related fieldAt least 2 years of experience in a regulatory operations roleMinimum of 1 year of experience publishing and validating electronic submissions (IND, MAA, NDA & CTAs)Experience using ISI / TRS Toolbox and eCTD publishing toolsFamiliarity with eTMF software and TMF regulatory zones

1 day ago
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