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Regulatory Affairs Specialist

Splendid Pharma
Sheraton, Cairo
Posted 4 years ago
67Applicants for1 open position
  • 46Viewed
  • 0In Consideration
  • 0Not Selected
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Job Details

Experience Needed:
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Job Description

  • Registration of new products.
  • Maintaining licenses of registered products.
  • Submitting variations of existing products.
  • Dealing with existing products and expanding company portfolio with new products including: pharmaceuticals.
  • Building up & submitting files to competent authority
  • Prepare analytical files to be submitted to different authorized labs
  • Follow up analysis and supply all needed requirement to get release certificates f samples.
  • Maintaining communication & following up with the competent authorities and internally
  • Maintain systems of regulatory work up to date
  • Support logistic team with all references , legalized certificates and material needed for regular analysis and release
  • Support MER with any needed support

Job Requirements

  • Max. 5 years experience in the same field
  • Deep experience  in pharmaceutical industry from a regulatory affairs perspective
  • Knowledge of pharmaceutical legislation, relevant guidelines, procedures and requirements
  • Fluent in oral and written Arabic and English
  • IT skills
  • Pharmacist is a must
  • self motivated and dynamic

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