Regulatory Affairs Officer

Description

Submit and follow up on registration and re-registration files for company products (local and imported) with the Egyptian Drug Authority (EDA).
Ensure proper follow-up with EDA until obtaining final approvals and registration licenses.
Submit product files and samples to CADC and follow up on analysis until final product conformity is achieved.
Handle documentation including Free Sale Certificates, GMP Certificates, and factory licenses issued by CAPA.
Review and finalize outer and inner packaging materials in coordination with the Regulatory Affairs Manager and ensure approval from EDA.
Ensure compliance with company policies, regulations, and ethical standards.
Perform any additional tasks assigned by the direct manager related to the role.

Requirements

• Bachelor’s degree in Pharmacy, Veterinary Medicine, or Science.
• 2-4 years of experience in Regulatory Affairs.
• Strong knowledge of regulatory requirements and processes.
• Excellent Microsoft Office skills.
• Experience dealing with different regulatory platforms.
• Strong communication, problem-solving, and strategic thinking skills.