Export regulatory affairs Specia...
6th of October, Giza
Export regulatory affairs Specialist
6th of October, Gizaposted 1 month ago22Applicants for1 open position
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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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