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Regulatory Affairs Specialist

Full Time
On-site
Rameda - 
6th of October, GizaPosted 2 months ago
219Applicants for1 open position
  • 26Viewed
  • 11In Consideration
  • 108Not Selected
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Job Details

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Job Description

  • Manage new applications submission corresponding to company plan as well as the authority guidelines for submission.
  • Manage review and submission of all maintenance activities (renewal & variations) based on company plans and the authority guidelines.
  • Maintain the products labelling up to date
  • Following strictly all the Authority Regulations, decisions & decrees.
  • Carry out all communication and follow up required with EDA and internally
  • Familiar with all regulations to support day to day activities.
  • Respect quality and compliance aspects.

Job Requirements

BSC in pharmacy 

experience From 1-3 years of regulatory affairs 

Knowledge of preparation of CTD files/ dealing with Extedo program

Working in regulatory affairs in different export countries is an add

 

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