Local Regulatory Affairs Specialist

Pharaonia Pharma

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.
• 1-2 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.