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Regulatory Affairs Coordinator

Parkville Pharmaceuticals
Mohandessin, Giza
Posted 4 years ago
174Applicants for2 open positions
  • 32Viewed
  • 0In Consideration
  • 0Not Selected
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Job Details

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Job Description

  • Ensure company products comply with the regulations of MOH.
  • Review Company related practices, handle regulatory inspection and provide advice on required modification to the company system according to governmental policies, regulations and updates.
  • Prepare and review all types of registration dossiers to be submitted to regulatory authorities and following up till get approval. (Stability, NODCAR, Inserts & Packs).
  • Follow up of submitted variations of existing products.
  • Responsible for preparation of dossiers of all registered products.
  • Responsible for submissions & follow up of files documents in the required timelines.
  • Arrange documents needed for Logistics & Custom clearance.
  • Responsible for preparation & Submission dossiers to NODCAR.
  • Track and ensure the completions of the registered products.
  • Ensure compliance, implementation of product labels and accuracy of updating all regulatory electronic emailing.
  • Submit documents for Pharmacovigilance.

Job Requirements

  • Bachelor degree of Pharmacy, Veterinary or Science.
  • Experience from 1-3 Years in the same position.
  • Demonstrate attention to details.
  • Proficiency with Microsoft Outlook, Word and Excel.
  • Ability to execute multiple orders of assignments without errors.
  • Very Good command of English.
  • High communication and presentation skills.

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