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Export Regulatory Affairs Pharmacist

Orchidia Pharmaceutical Industries
Obour City, Cairo
Posted 3 months ago
157Applicants for2 open positions
  • 150Viewed
  • 9In Consideration
  • 141Not Selected
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Job Details

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Job Description

  • Coordinate all Export Registration Related activities. 
  • Study Export Regulatory documents scientific and legal documents.
  • Reply to letters and requested information and/or materials by foreign government agencies for the purpose of Registration of the products 
  • Obtain Marketing Authorization in foreign markets.
  • Obtain/generate information to be submitted to foreign regulatory authorities and prepares required regulatory documentation & dossiers.
  • Ensure compliance with MOH regulations in Export countries. 
  • Liaising and negotiating with foreign regulatory authorities.
  • Keep up-to-date with changes in Export regulatory legislation and guidelines.
  • Perform any other duties assigned by management related to Export DRA.

 

Job Requirements

  • From 1to 3 years’ Experience in Export/ Local Regulatory Affairs.
  • Bachelor's degree in pharmacy.
  • Background knowledge of regulatory applications and procedures.
  • Excellent English, verbal / written communication.
  • Excellent computer skills.
  • Interpersonal & communication skills.
  • Careful planning to achieve accurate and timely results.
  • Ability to work precisely according to procedures, rules and regulations.
  • Recognize recurring issues and analyze their causes in order to reach a solution.

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