Regulatory Affairs Specialist
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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