Regulatory Affairs - Section Head

IBE Pharma Cairo

Applicants for
1 open position
Experience Needed:
3 to 5 years
Career Level:
Job Type:
Full Time
4,000 to 5,000 EGP per month
1 open position
Job Categories:
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 a change in pack, formula or name.
  • Establish and maintain a 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 with 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 a registration track record for the market
About this Company

International Business Establishment ( I.B.E.) & Thita Pharmaceutical Industries (T.P.I) are sister companies, TPI is a factory which 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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