📌 Key Responsibilities:Prepare and review CTD dossiers for submission to the Egyptian Drug Authority.Execute regulatory activities for new registrations, variations, and renewals.Follow up with EDA on submitted files and handle deficiency letters and responses.Ensure submitted documents comply with local Egyptian and veterinary requirements.Coordinate with internal departments (R&D, Quality, Production) to collect required documents.Track submission timelines and maintain proper documentation records.Support pilot batch follow-up and stability data compilation.Assist in audit readiness and regulatory documentation support.Guide junior team members on daily regulatory tasks.📌 Qualifications:Bachelor’s degree in Pharmacy or Veterinary Medicine (Pharmacy preferred).7–13 years of experience in Regulatory Affairs in Egypt (human & veterinary).Hands-on experience with EDA submission processes.Strong knowledge of CTD format and lifecycle activities.Experience in handling deficiency responses and follow-ups.📌 Preferred Skills:Good organizational and follow-up skillsAttention to detail and compliance awarenessAbility to manage multiple files simultaneouslyBasic team supervision