YH

Yasmine Hashem

Regulatory Affairs Section Head at HPG company

Cairo, Egypt

Work Experience

  • Regulatory Affairs PharmacistFull Time

    Vamer Pharma

    Feb 2021 - Present -4 yrs, 5 months

    Egypt , Cairo

    • Job Details:-Establishing food supplement sector Reviewing food supplement dossiers for submission & following up with the National Food Safety Authority (NFSA) in Egypt, submitting appeals & attending meetings Dealing with agents abroad providing them with the most updated data regarding the registration guidelines in Egypt Coordinating with various company's departments Responsible for the Research and Development of food supplement products, searching for new moieties to be registered and creating formulas Contacting factories for contracts & raw material suppliers
  • Regulatory Affairs Section HeadFull Time

    HPG company

    Nov 2019 - Present -5 yrs, 8 months

    Egypt , Cairo

    • Job Details:Deputy Manager; assure timely submission of technical documents to the MOH, supervise a team of 5.   -Resolve internal & external issues.  -Reviewing food supplement, cosmetic & pharmaceutical products' dossiers for submission  & following up with the National Food Safety Authority in Egypt (NFSA), the Egyptian Drug   Authority (EDA) & the National Nutrition Institution (NNI).  -Preparing & reviewing stability files, box inquiries, cosmetic files, pricing appeals & biological files.  -Representing the company at the pricing committee & meetings with NFSA upper management.  -Dealing with agents abroad providing them with the most updated data regarding the registration guidelines in Egypt.  -Coordinating with various company's departments.  -Dealing with inspections & inspectors.  -Representing the company at NFSA, NNI & EDA.
  • Regulatory Affairs SeniorFull Time

    Central Administration for Pharmaceutical Affairs

    Mar 2011 - Oct 2019 -8 yrs, 7 months

    Egypt , Cairo

    • Job Details:Assessing companies’ applications submitted for drug product registration in the Boxes team. -Reviewing drug product dossiers according to the ministerial decrees 296, 645 & 370 in the Hard files team. -Communicating with different companies via the reception & emails. -Communicating with the various CAPA departments. -Issuing approvals for pharmaceutical products
  • Education

    • Bachelor's Degree in Pharmaceutical sciences

      Ain Shams University (ASU)

      Jan 2009 

    Skills

    • Precision Time Protocol
    • Detail Oriented
    • English Translation
    • Microsoft Office
    • Communication
    • Presentations
    • Team Player

    Languages

    • English

      Fluent
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