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Regulatory Affairs Specialist

IBE Pharma
Nasr City, Cairo

Regulatory Affairs Specialist

Nasr City, CairoPosted 1 month ago
243Applicants for1 open position
  • 57Viewed
  • 0In Consideration
  • 0Not Selected

Job Details

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Job Description

  • Responsible for preparation of Registration dossiers of all new products and Re-registered products.
  • Responsible for preparation and submission of Analytical dossiers to NODCAR ( National Organization for Drug Control and Research )
  • Follow up all steps of registration in MOH (Ministry of Health) including Stability Study, Bioequivalence Study, Inserts, Packs and Analysis.
  • Follow up any change needed in any product such as a change in pack, formula or name.
  • Establish and maintain a good relationship with the internal and external stakeholders.
  • Coordinate with the R&D, Q.C, Production, Marketing team members regarding the different registration issues.
  • Ensure all registration activities are in compliance with the company and National laws & regulations.
  • Ensures confidentiality in respect of registration files contents.
  • Carefully review compiled files to ensure that content, quality, accuracy and format of submission Comply with applicable regulations of the market.
  • Develop and maintain a registration track record for the market

Job Requirements

  • Experience in the dietary supplement and human drugs.

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