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Regulatory Affairs Specialist

Delta Pharma Egypt
Heliopolis, Cairo
Posted 3 years ago
337Applicants for1 open position
  • 82Viewed
  • 6In Consideration
  • 30Not 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
  • 1-2 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
  • Awareness & adherence to company internal SOPS & compliance standards promptness in deliverables & in response to authorities’ requirements
  • Understand the link between own priorities & the organization.

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