Regulatory Site Officer (RSO) Specialist
Core
Prepare and submit pharmaceutical product registration files to the Egyptian Drug Authority (EDA), manage regulatory relationships with inspectors, and coordinate cross-functional activities to maintain product approvals.
Role type
Regulatory Site Officer (RSO) Specialist
Builds
Regulatory submissions and product approvals for the Egyptian market
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory file preparation, Gap analysis, Stability data management, Variation submission, Inspector liaison, HSE compliance
Preferred skills
Regulatory activities experience, English language proficiency
Technologies
None stated
Responsibilities
Prepare IA part of regulatory files for new and renewal products, Review and approve updated methods of analysis, Manage submission of variations to close regulatory gaps, Coordinate with EDA inspectors on product release and sampling, Ensure HSE approval on SOPs and changes
Seniority
L1-2 (Entry level)