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CW. Senior Associate Regulatory Affairs - United Arab Emirates  

Amgen (company)


Posted on : 07 May 2017

Project Description

Ensure delivery of right first time label source text for artwork creationSupport efficiently the different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) and artworks in a timely mannerPerform label management within the system from CDS (product core data sheet) update to variation/MAA submission in the regionAccess the translation agency systems to request the label translation and track the job readiness.Perform regional prescribing information translation review: 100% review of both content and formatPerform the role of source text approver and artwork reviewer and approver in the systemTrigger the existing label revision when alerted by global RA team.Support in making product ready for supply by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)Disseminate relevant information to team(s) as appropriateParticipate in local regulatory process improvements initiativesCollate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.Ensure delivery of right first time label source text for artwork creationSupport efficiently the different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) and artworks in a timely mannerPerform label management within the system from CDS (product core data sheet) update to variation/MAA submission in the regionAccess the translation agency systems to request the label translation and track the job readiness.Perform regional prescribing information translation review: 100% review of both content and formatPerform the role of source text approver and artwork reviewer and approver in the systemTrigger the existing label revision when alerted by global RA team.Support in making product ready for supply by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)Disseminate relevant information to team(s) as appropriateParticipate in local regulatory process improvements initiativesCollate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.

Locations

United Arab Emirates Dubai

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