Experience

• 

  Sanofi

  • France
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Senior Regulatory Affairs Specialist ,COE (GenMed &Speciality Care) (Egypt,Sudan and Iraq)

    • Jun 2022 - Present

    • Post-approval changes dossier evaluation, preparation and dispatch to the countries for submission in line with local regulations and planning set up by Global/Regional BU/Country regulatory team. • Implement all activities in timely manner and align with Regional BU/country strategy • Maintain a good working relationship • Foster an environment/culture of learning and sharing of best practice within the team • Cross Functional Collaboration with: ➢ AMEE COE Cluster Heads ➢ Regional/Affiliate RA Heads ➢ Regional/Affiliate Managers ➢ Regional/Affiliate Associates ➢ CMC department ➢ Labeling department ➢ RSOs ➢ Regulatory Excellence teams • Ensure preparation of ready- to- submit regulatory dossier • Ensure the management of the artworks • Ensure update the databases • Ensure the administrative documents related with PoA, CPP • Ensure all documents are translated in compliant with Health Authority requirements • Ensure regulatory compliance with products and country requirements • Ensure compliant with all internal and external requirements, procedures and tools.

  • Regulatory Affairs Specialist,Center Of Expertise

    • Dec 2019 - Jun 2022

• 

  Pfizer

  • Egypt

  • ALIM Artwork and Labelling Implementation coordinator (ASIA /AFME )

    • Apr 2018 - Nov 2019
    • Egypt
• 

  Multipharma

  • Cairo

  • Lot release and regulatory affairs associate

    • Aug 2016 - Apr 2018
    • Cairo
• 

  El Ezaby Pharmacy

  • Shiftmanager

    • Oct 2013 - Aug 2016