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Regulatory Affairs Officer - Pharmacy

Magicpharma
Giza, Egypt
Posted 2 years ago
123Applicants for1 open position
  • 36Viewed
  • 8In Consideration
  • 28Not Selected
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Job Details

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Job Description

  • Prepare / submit / follow up of under-registration, registration & re-registration files for the company’s products (Dermocosmetics and nutraceuticals) at EDA₁ & NFSA₂.
  • Prepare/submit / follow-up files & sample the analysis of finished goods in EDA until receiving the final conformity of the product.
  • Work in revising/submitting final outer and inner packs data at EDA, until receiving EDA approval and before shipping processes, revising final films from printing house.
  • Work in revising/submitting new insert leaflets until receiving EDA approval, translating of PIL₃ to Arabic leaflet at EDA automation system, revising final films from the printing house.
  • Present to various committees until receiving the final registration licenses.
  • Prepare /follow up on variation, stability, inserts, packs, and licensing of Magicpharma Importation license, until receiving EDA approval.
  • Work in submitting/receiving the medical approvals on DC₄ finished goods and raw materials.
  • Deputize the regulatory affairs manager to attend meetings and to deal with middle management in EDA.
  • Work in Preparing / submitting the security approvals until receiving general security section approval.
  • Establish and Maintain regulatory transformation program RTP₅ related to the imported section.
  • Perform any other task assigned by the direct manager related to the field of work.
  • Ensure that the company they work for is aware of all applicable EDA / NFSA regulations.
  • Ensure of company regu-legal EDA, GOEIC₆, NFSA licenses to be up to date.

Job Requirements

  • Male 
  • Age 23 : 25 years 
  • Pharmacy degree.
  • Ownership of a transportation vehicle ( Car, Motorcycle )

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