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Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
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
Desired Candidate Profile
Essential qualifications & experience
- Bachelor s degree in pharmacy, Pharmaceutical Sciences or related life sciences field
- 1 3 years Regulatory Affairs experience in a multinational pharmaceutical company, with strong exposure to SFDA submissions and Saudi market requirements
- Fluent in Arabic and English (written and spoken)
- Deep understanding of SFDA regulations, eCTD requirements, labelling standards and regulatory lifecycle management
- Strong organizational, project coordination and communication skills; ability to manage multiple priorities under tight timelines
- Demonstrated experience implementing regulatory change and SOPs consistent with global/local RA frameworks
- Strong stakeholder engagement and negotiation skills
Mandatory
- Saudi national
- Saudi licensed pharmacist
Nice to have
- Exposure to price negotiation or pricing appeals with SFDA
- Experience liaising with scientific office or providing pharmacovigilance oversight
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Regulatory Affairs Specialist
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GlaxoSmithKline
GSK Saudi Arabia is committed to supporting Vision 2030 and the Saudi Arabian National Agenda including Saudization in line with the hiring and the training and development of Saudi National capability. /b> b> /b> /p> /p> Role overview/b> br>We are seeking a Regulatory Affairs Officer to support SFDA submissions, lifecycle management, labelling and cross functional regulatory activities for locally marketed and globally supplied products. This is an in office role based in Riyadh and involves close coordination with global RA teams, local site QA/RA contacts, commercial, medical, supply and external partners./p>