Associate I– Reg CMC Strategy (LEC Team)
About this role
Associate I– Reg CMC Strategy (LEC Team)
JOBSUMMARY
Functions as a Strategist for Brands-LEC team, working with Global Regulatory Strategist (GRS-CMC) and CrossFunctionalTeamstoprepareandsubmitthevariationsforentitynamechangeacrossglobalmarkets including US, EU & ROW as per defined timelines.
JOBRESPONSIBILITIES
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Managesday-to-dayregulatoryactivitiesassociatedwithassignedLECvariationswithinagreed upon timelines.
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Evaluate changecontrolsforcompleteness,accuracy andrequiredsupporting documents.Initiate change controls when needed.
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PerformsMarketImpactAssessment(MIA)forthespecificentitynamechange.
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RunstheRegAtlastodeterminethefilingactionandimpactedsections specific for entity name change and to obtain confirmation from the Regional Regulatory Lead.
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