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Export regulatory affairs Specia...

Al Andalous Pharmaceutic...
6th of October, Giza
Al Andalous Pharmaceutical Industries logo

Export regulatory affairs Specialist

6th of October, GizaPosted 23 days ago
18Applicants for1 open position
  • 0Viewed
  • 0In Consideration
  • 0Not Selected

Job Details

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Job Description

  • Prepare, review, and submit regulatory dossiers (CTD, , eCTD) for new product registrations and variations across international markets .
  • Maintain up-to-date knowledge of regulatory requirements and changes in targeted countries.
  • Liaise with health authorities and regulatory agents to follow up on submissions and respond to queries.
  • Collaborate with R&D, Quality Assurance, and QC departments to gather necessary documentation for regulatory submissions 

 

Job Requirements

  • Bachelor's degree in Pharmaceutical Sciences, Science or a related field .
  • Experience (1-3) years of in Regulatory Affairs, preferably with international exposure.
  • Solid knowledge of global regulatory frameworks (WHO, ICH, GCC, SFDA, etc.).
  • Familiarity with CTD/ eCTD formats.
  • Strong communication skills in English (written and verbal); French is  a plus.
  • Excellent organizational, time management, and problem-solving skills.
  • Ability to work independently and collaboratively in a cross-functional team.
  • Pharmaceutical Experience is a must .
  • 6th October City resident and nearby are preferred .

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