Regulatory Affairs Section Head

📌 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 skills
• Attention to detail and compliance awareness
• Ability to manage multiple files simultaneously
• Basic team supervision