Regulatory Affairs Specialist
Full Time
Cairo
Posted 7 months ago
Key Accountabilities:
- Present the new products to the marketing department for study.
- Prepare the annual and semi-annual registration plan with the export section for the required products to be registered.
- Search for procedures for registering the products in the concerned country.
- Prepare and processing the product file for registration.
- Submit the documents required to register the factory in the importing country according to the laws of each country.
- Determine dates for external inspection visits from the importing countries.
- Submit files (registration – pricing) to central administration for pharmaceutical products and the concerned country and following up on the steps after submission.
- Submit a petition in the event of any decision impeding registration or inappropriate pricing.
- Follow-up issuance of approval for the product and obtain the final notification from the central administration for pharmaceutical products. (Final Notice – Temporary Notice)
- Prepare a trial batch to study the stability and adding it to the product file.
- Submit the stability file on the specified date in central administration for pharmaceutical products – the stability department.
- Submit the required documents in the event of a change to any product.
- Apply to the Department of Approved Bulletins and notifying the specialists in issuing product pamphlets of the requirements of the central administration for pharmaceutical products.
- Ensure that the customer receives the initial approvals and starts the first batch.
Qualification Requirements:
- Bachelor of Pharmacy.
- 1-3 Years of experience in a similar position.
- Computer skills, Negotiation & Communication skills.
- Good Command of the English Language.
- Organization skills and high accuracy in documentation.
- High sense of urgency.
- Knowledge of new decrees & Guidelines.
- Time management.
- Understand the link between own priorities & the organization.
Job Features
Job Category | Registrations |