Regulatory Affairs Specialist At Elixir Pharma

We’re Hiring: Regulatory Affairs Specialist!

Elixir Pharma is looking for a talented Regulatory Affairs Specialist to join our growing team.
📍 Work Location: Sheraton Heliopolis, Cairo.

The key responsibilities of the job would be:

– Prepare, review, compile, and follow up on regulatory submissions for human pharmaceutical products, including new registrations, re-registrations, renewals, variations, and post-approval changes.
– Handle CTD dossier documentation and coordinate with internal departments (QA, QC, R&D, Production, and Supply Chain) to collect and review the required technical documents.
– Follow up with Egyptian Drug Authority (EDA) departments and respond to regulatory queries in a timely and organized manner.
– Review and maintain regulatory documentation, including composition, specifications, stability data, batch analyses, manufacturing documents, GMP certificates, CPP/COPP, artwork, package inserts, mock-ups, and administrative documents.
– Monitor regulatory updates, EDA circulars, guidelines, committee decisions, and submission requirements, and communicate their impact internally.
– Maintain regulatory trackers and ensure timely follow-up on pending submissions, authority comments, commitments, and approval timelines.
Support communication with local and foreign manufacturers, API suppliers, licensors, consultants, and regulatory agents when required.

Technical Knowledge

– Good knowledge of Egyptian Drug Authority (EDA) regulations and procedures.
– Solid understanding of CTD structure and regulatory documentation.
– Familiarity with registration, re-registration, renewals, variations, stability requirements, bioequivalence documentation, package inserts, mock-ups, and post-approval changes.
– Experience with the EDA One Submission / CTD submission system is an advantage.

What we are looking for in the ideal candidate:

– Bachelor’s degree in Pharmacy is preferred. Candidates with a degree in Science or Veterinary Medicine may also be considered if supported by relevant regulatory affairs experience.
– 1–3 years of experience in pharmaceutical regulatory affairs.
– Experience with generic pharmaceutical products and EDA submissions is highly preferred.
– Excellent command of written and spoken English.
– Proficiency in Microsoft Office, especially Word and Excel.
– Strong attention to detail and excellent document control practices.
– Good communication, coordination, and follow-up skills.
– Ability to work under pressure and manage multiple regulatory files simultaneously.
– Organized, committed, and capable of working effectively with cross-functional teams.

Ready to join and make an Impact:
If you are Interested, kindly send your updated CV to hr@elixirpharma-eg.com
Subject: Regulatory Affairs Specialist.