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Regulatory Affairs Specialist

GlaxoSmithKlineRiyadh, KSA3 weeks agoMid-Senior
Regulatory Affairs Specialist
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About This Role

Key responsibilities

  • Prepare, submit and follow up SFDA applications for new products, renewals and variations in line with global submission strategies
  • Maintain product licenses and manage timelines for renewals, changes and variations
  • Coordinate and review regulatory labelling and packaging (including Arabic translations) to ensure SFDA compliance
  • Support regulatory projects and liaise with global and local stakeholders to deliver required RA activities
  • Coordinate locally manufactured product changes with site RA and quality teams
  • Monitor SFDA and regional regulatory updates; assess impact and communicate to stakeholders
  • Serve as primary RA contact for internal teams and external agents/distributors; represent GSK in regulatory meetings as needed
  • Maintain regulatory tracking dashboards and audit ready documentation, support health authority inspections
  • Communicate with SFDA via approved channels and arrange meetings with relevant SFDA departments when necessary
  • Provide cross functional regulatory support for tender submissions, promotional material approvals and product supply strategy

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