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CW. Senior Associate Regulatory Affairs Dubai United Arab Emirates,  

Amgen (company)


Posted on : 07 May 2017

Project Description


Description:
  • Ensure delivery of right first time label source text for artwork creation
  • Support 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 manner
  • Perform label management within the system from CDS (product core data sheet) update to variation/MAA submission in the region
  • Access 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 format
  • Perform the role of source text approver and artwork reviewer and approver in the system
  • Trigger 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 appropriate
  • Participate in local regulatory process improvements initiatives
  • Collate, 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 creation
  • Support 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 manner
  • Perform label management within the system from CDS (product core data sheet) update to variation/MAA submission in the region
  • Access 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 format
  • Perform the role of source text approver and artwork reviewer and approver in the system
  • Trigger 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 appropriate
  • Participate in local regulatory process improvements initiatives
  • Collate, 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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