Key Accountabilities:

• Prepare the annual and semi-annual registration plan with the Export Department for the products to be registered.
• Research the registration procedures for the product in the relevant country.
• Prepare and organize the product file for registration.
• Submit the required documents to register the manufacturer in the importing country according to each country’s regulations.
• Schedule and follow up on the external inspection visits from the importing countries with the relevant agent for each country.
• Submit the registration and pricing files to the Pharmacy Administration in the relevant country and follow up on the post-submission process.
• Submit a petition in case of any decision that hinders the registration or if the pricing decision is unfavorable.
• Follow up on the approval process for the product and obtain the final notification from the Pharmacy Administration of the importing countries (Final Notification – Temporary Notification).
• Follow up on the commitments made with the registration file to submit stability studies required by each country and add them to the product file.
• Submit the required documents in case of any changes to a product.
• Submit to the Approved Circulars Department and inform the specialists who issue product circulars according to the Pharmacy Administration’s requirements.
• Ensure the customer has received the preliminary approvals and begin the first batch production.
• Prepare a consolidated report that includes all registered products in each country, whether new or old.
• Prepare a report of new and old products in the Egyptian Pharmacy Administration by trade type (export or tenders).
• Follow up on the required studies for product registration and bioequivalence studies (bioequivalence-dissolution rate) at the specialized centers.
• Follow up on the necessary external certificates and verifications required for product registration, according to each country’s requirements, and add them to the product file.
• Prepare the budget required for product registration in the importing countries annually, based on each country’s requirements.
• Follow up on the shipments of registration files from their departure from the factory until their arrival in the relevant country.

Qualification Requirements:

• bachelor’s degree in pharmacy, veterinary medicine, or science.
• Experience from 1 to 3 years.
• Must have Experience in CTD file preparation for Export.
• Fluent in computers.
• Fluent in English.
• Communication and problem-solving skills.
• Negotiation and teamwork abilities.
• Time management and planning proficiency.
• Presentation, creativity, and innovation skills.
• Responsibility and adaptability.