Export Regulatory Affairs Specialist

Full time
Cairo
Posted 5 days ago
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.
Job Features
Job Category | Registration |