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Regulatory Affairs Senior Specialist (Local)

Delta Pharma Egypt
Heliopolis, Cairo
Posted 3 years ago
80Applicants for1 open position
  • 65Viewed
  • 14In Consideration
  • 51Not Selected
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Job Details

Experience Needed:
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Job Description

  • Compile and maintain regulatory documentation databases or systems.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Analyze product complaints and make recommendations regarding their re-portability.
  • Develop or conduct employee regulatory training.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
  • Submit and follow up stability files
  • Submit and follow up Nodcar files
  • Submit and follow up  Bioequivalence files
  • Submit and follow up pharmacology & naming files
  • Submit and follow up variation files

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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