أخصائي شؤون تنظيمية (تصدير)

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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: [اضغط هنا لمشاهدة البريد اﻹلكتروني]

Subject Line: Regulatory Affairs Specialist - El Arabi Pharma

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