Lead the regional regulatory strategy for Pharco's product portfolio across the MENA markets. Acting as the primary interface with health authorities in Egypt, Gulf states, and Levant, you will manage a team of regulatory specialists and ensure timely product registrations and renewals.
Key Responsibilities
Develop and execute regulatory strategies for new product registrations and lifecycle management
Manage a team of 3 to 5 regulatory affairs specialists
Liaise directly with CAPA, SFDA, MOH authorities across Egypt and GCC
Review and approve regulatory submissions, labelling, and post-approval changes
Monitor regulatory intelligence and advise leadership on emerging requirements
Requirements
B.Sc. in Pharmacy; M.Sc. or advanced regulatory qualification preferred
7+ years in regulatory affairs with at least 3 in a managerial role
Proven track record of successful submissions to MENA health authorities
Strong understanding of CTD/eCTD submission formats
Fluent Arabic and English (written and spoken)
Nice to Have
RAC (Regulatory Affairs Certification) from RAPS
Experience with biologics or biosimilar registrations
Established relationships with SFDA or CAPA reviewers
