Regulatory Affairs Specialist

Splendid Pharma - Sheraton, Cairo

Applicants for
1 open position
Experience Needed:
3 to 5 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Confidential, medical insurance
Arabic, English
1 open position
Job Roles:
About the Job
  • 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
About this Company

Splendid is a representative office for pharmaceutical multinational companies in the Middle East acting as their Regional Offices, taking the responsibilities of all sales & marketing activities.

In 2009, Dr. Gamal El-Sheikh launched this modern... (More)

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