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Regulatory Affairs Specialist

Knoz Elhekma
Nasr City, Cairo
Posted 6 years ago
108Applicants for2 open positions
  • 18Viewed
  • 9In Consideration
  • 0Not Selected
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Job Details

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Job Description

Job Brief

We are looking for regulatory affair responsible for company Saudi government web accounts:

  • Saudi FDA products registration food, cosmetics and medical devices
  • Importing process including custom clearance and shipment follow with exporter

Responsibilities

  • 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 change in pack, formula or name.
  • Ensure all registration activities are in compliance 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 registration track record for the market

Job Requirements

Requirements

  • Experience: 1 - 3 in regulatory affair is preferable
  • BSc/BA in relevant field
  • Proficient level of written and spoken English language
  • Knowledge of regional laws and regulations relating to pharmaceutical product registration

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