Regulatory Affairs Specialist
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Key skills for this role
About the Role
Prepare and submit SFDA applications, maintain product licenses, and support regulatory projects with strong organizational and communication skills required.
Key Skills for This Role
Full Job Posting
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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