Noha Safwat

Experience

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  EIPICO

  Jan 2010 - Mar 2015

  Regulatory Affairs Specialist

  Senior Regulatory Affairs Specialist• Export registration officer responsible of regulatory requirements and preparing eCTD/CTD files for multiple countries in Europe, Asia, South America and Africa.• Training of new RA comers, assigning sites, distributing work load, follow up with team and coaching them through any problems.• knowledge of current guidelines and regulations, SOP preparation, regulatory submissions, regulatory compliance issues, streamlining of procedures, updated GLP, GMP, Quality Assurance and Quality Control. Show less

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  Egyphar

  Mar 2015 - Apr 2018

  Regulatory Affairs Associate Manager

  Managed an international team of regulatory affairs personnel to develop a registration process in different countries• Developed a project strategy to ensure that the registration needs of various countries were met, risks were minimized and international product-submittal processes were streamlined.• Engage global regulatory partners, verbally and through written communications to discuss pending or new registrations, regulatory requirements, etc.• Prepare technical files and international product registration dossiers.(NeeS-CTD-eCTD)• Review and analyze technical protocols, data, and reports generated by various functional groups such as Product Engineering/R&D…• Review and approve proposed labeling, packaging, and/or advertising and promotional materials in accordance with regulations.• Preparation of BE files with follow up with the third party center and Health Authority. Show less

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  ADWIA Pharmaceuticals

  Nov 2020 - now

  Global Regulatory Affairs Section Head