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full timeregulatorySharjah, UAE
Regulatory Affairs Specialist
About This Role
Manage MOHAP/GCC regulatory submissions, maintain product dossiers, and support global registration strategies for ALKENDI's product portfolio.
Key Responsibilities
- Prepare and submit MOHAP/GCC registration dossiers
- Manage variation and renewal lifecycle
- Coordinate with manufacturing/QA for data compilation
- Monitor regulatory intelligence (GCC, MENA, WHO)
- Support pharmacovigilance and PQRS requirements
- Maintain regulatory tracking and metrics dashboard
- Liaise with health authorities during inspections
Requirements
- BSc/MSc in Pharmacy, Regulatory Science, or Life Sciences
- 3+ years regulatory affairs in pharma (GCC experience preferred)
- MOHAP, SFDA, GCC-DR submission experience
- CTD/eCTD dossier preparation and publishing
- Variation, renewal, and post-approval management
- Strong project management and communication skills
Apply for Regulatory Affairs Specialist
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