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Senior Regulatory Affairs Specialist (Export)

Delta Pharma Egypt
Heliopolis, Cairo
Posted 1 year ago
117Applicants for1 open position
  • 89Viewed
  • 14In Consideration
  • 76Not Selected
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Job Details

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Job Description

  • Presenting the new products to the marketing department for study.
  • Preparing the annual and semi-annual registration plan with the export section for the required products to be registered.
  • Searching for procedures for registering the products in the concerned country.
  • Preparing and processing the product file for registration.
  • Submitting the documents required to register the factory in the importing country according to the laws of each country.
  • Determining dates for external inspection visits from the importing countries.
  • Submitting 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)
  • Preparing 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.
  • Applying 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

Job Requirements

  • Bachelor of Pharmacy, Science, or Vet
  • 3-5 Years of experience in a similar position (Preferable Export Experiences and Local Background)
  • 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

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