Jr. Publisher – Regulatory Affairs - Old Bridge

Only for registered members Old Bridge, United States

2 weeks ago

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Job Summary:

Jr. Publisher – Regulatory Affairs

Location:
Bridgewater,NJ,,Global Submission/Publishing of all submissions from a Global perspective and dispatches to worldwide Health Authorities (FDA, EMA,LATAM,RW).Accountable for all Publishing,verification,dispatch.Working in close collaboration with the Franchise Head of Global Submission Publishing and Global Submission managerassigned to respective franchise/activitywith clear accountability for publishing process.Supporting implementation of Technical Format requirementsand collaborates with DRA Operations Submission Standardsand Strategy team members to develop companys business guidance on publishing deliverables.

Responsibleformanagingallaspectsoftheregulationalsubmissionprocessincludingpreparationtrackingcompilationpublishing,andtechnicalqualitycontrolofallsassignedmaintenance regulatorysubmissionsfor assignedfranchise.EnsuringadherenceinternallystandardsandprocessesaswellasHealthAuthoritiesrequirements.ReportingupdatingFranchiseHeadsSubmissionPublishingsubmissionprogress.ProvidemonthlyreporttoimmediateandlemanagementswithinDRAOps.Identifyingissuesandsolutionsrelatingtotimingqualityandreources.

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