‏⁦We are Hiring: Regulatory Affairs Specialist (Export)
El Arabi Pharma is seeking a qualified and detail-oriented Regulatory Affairs Specialist to join our dynamic team and support our expanding pharmaceutical export operations.
If you have hands-on experience in pharmaceutical regulatory affairs and cross-border drug registration, we’d love to hear from you!
location : Elmokattam
Key Responsibilities: Prepare, compile, and review pharmaceutical registration dossiers (CTD / eCTD) for targeted export markets. * Coordinate with the Egyptian Drug Authority (EDA) and regulatory bodies in importing countries to ensure smooth registration processes. * Issue and renew drug registration certificates, Free Sale Certificates (FSC), and Good Manufacturing Practice (GMP*) documents. * Review patient information leaflets (PIL), packaging materials, and outer labeling to align with destination market regulations. * Stay up to date with evolving international pharmaceutical regulations, guidelines, and compliance requirements.
Qualifications & Requirements: Education: Bachelor’s Degree in Pharmacy (PharmD / B.Pharm) is required. * Experience: Proven experience (2–4 years) in regulatory affairs within the pharmaceutical industry, preferably in drug export. * Languages: Full professional proficiency in English (written & spoken). * Technical Skills: Strong understanding of CTD/eCTD guidelines, EDA regulations, and registration procedures across key export regions (e.g., Africa, Gulf, CIS). * Key Traits:* High attention to detail, strong communication skills, and excellent deadline management.
What We Offer:
üì© How to Apply:Interested candidates are invited to send their updated Resume / CV to:
üìß Email: [email protected]
üìå Subject Line: Regulatory Affairs Specialist - El Arabi Pharma
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