Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist will support the Regulatory Affairs Manager in managing product registrations across multiple countries. The role involves coordinating with suppliers, authorities, and internal teams to ensure timely and compliant submissions.

Key responsibilities

• Interpret registration requirements for various countries.
• Request and collect required documentation from suppliers.
• Enter registration data into governmental systems and upload supporting documents.
• Analyze authority comments and communicate them clearly to suppliers.
• Participate in conference calls with suppliers, prioritize tasks, and convey requirements.
• Maintain an organized archive of registration records.
• Facilitate communication between authorities, local agents, and suppliers.
• Ensure compliance with internal Amico regulations.
• Handle additional regulatory activities such as classification, pre‑qualification, and recalls.
• Coordinate with the legal department on regulatory matters.
• Update SOPs as needed and monitor pending issues.
• Prepare progress reports on registration activities.

Required profile

• Bachelor’s degree or equivalent in Science, Pharmacy, Biomedical Engineering, Business Administration, or Law.
• Minimum 3 years of experience in Regulatory Affairs within a regional company handling a wide product range.
• Experience with medical device registration outside Egypt or registering Egyptian products abroad.
• Fluent English communication skills.
• Knowledge of pharmaceutical registration processes.
• Experience with Gulf region registrations is a plus.
• Additional certification in Quality or Regulatory Affairs is advantageous.

Required skills

• Excellent proficiency in MS Office (Word, Excel, PowerPoint).

What we offer

• A diverse and inclusive workplace that values different perspectives.
• Commitment to equal opportunity hiring practices.