Regulatory Affairs Manager

Egyptian Canadian Company - Cairo

49
Applicants for
1 open position
44
Seen
1
Rejected
Experience Needed:
2 to 3 years
Career Level:
Manager
Job Type:
Full Time
Salary:
4,000 to 5,000 EGP per month
Vacancies:
1 open position
About the Job
  • Responsible for preparation of Registration dossiers of all new products and Re-registered products.
  • Responsible for preparation and submission of Analytical dossiers to NODCAR ( National Organization for Drug control and Research )
  • Follow up all steps of registration in MOH (Ministry of Health) including Stability Study, Bioequivalence Study, Inserts, Packs and Analysis.
  • Follow up any change needed in any product such as change in pack, formula or name.
  • Establish and maintain good relationship with the internal and external stakeholders.
  • Coordinate with the R&D, Q.C, Production, Marketing team members regarding the different registration issues.
  • Ensure all registration activities are in compliance the company and National laws & regulations.
  • Ensures confidentiality in respect of registration files contents.
  • Carefully review compiled files to ensure that content, quality, accuracy and format of submission Comply with applicable regulations of the market.
  • Develop and maintain registration track record for the market
Job Requirements
  • Experience in dietary supplement and human drugs.....
About this Company

Egyptian Canadian Company & Thita Pharmaceutical Industries are sister companies for I.B.E.
ECC was established in 2007 and our factory is under construction based on the G.M.P. regulations, to be the manufacturer for its own products and I.B.E products & also as a TOLL... (More)

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