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Regulatory Affairs Specialist

APEX Pharma
Cairo, Egypt
Posted 5 years ago
186Applicants for1 open position
  • 166Viewed
  • 9In Consideration
  • 157Not Selected
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Job Details

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Job Description

  • Planning and Monitoring of the Regulatory Context
  • Registration of new products & re-registration of current products
  • Maintain and update labeling & variations
  • Carry out the planned RA Activities e.g. Pack Size Additions, Artwork Approvals
  • Preparation & submission of BE files with follow up with the third party center and Health Authority
  • Assure compliance with IA files
  • Price Preparation, submission & follow up of files and documents in the required Timelines.
  • Following and complying with all the defined internal policies and procedures of working.
  • Strictly following all the Authority Regulations, decisions & decrees.

Job Requirements

  • Bachelor of pharmaceutical / Sciences
  • 3-5 Years of experience in a similar position
  • Computer skills, Negotiation & Communication skills.
  • Good Command of English Language
  • Organization skills and high accuracy in documentation
  • High sense of urgency
  • Knowledge of new decrees & Guidelines
  • Time management

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