Regulatory Affairs Specialist (Export)

‏⁦ 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:Professional working environment fostering career growth. Competitive salary & compensation structure. Social and medical insurance. 📩 How to Apply: Interested candidates are invited to send their updated Resume / CV to: 📧 Email: [redacted email] 📌 Subject Line: Regulatory Affairs Specialist - El Arabi Pharma ⁩ Show more Show less