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Khaled Amin

MBA

Giza, Egypt

Work Experience

  • Front Office Team Leader for Biological Products RegistrationFull Time

    Central Administration of Pharmaceutical Affairs

    Feb 2014 - Present -11 yrs, 5 months

    Egypt , Cairo

    • Job Details:•Manage & Monitor all functions performed by the team including the following: 1.Reviewing request inquiry before issuing box approval. 2.Final review of registration files before issuing registration/renewal license. 3.Reviewing all letters, assessment reports & Technical committee appeals done by the team. 4.Reviewing and approving biological products pack labels. 5.Follow up of the committees’ decisions implementation •Member of Imported Products Stability Committee, responsible for revising and approving stability studies of imported products. •Preparation of guidelines, Standard Operating Procedures & work instructions. •Organizing the work flow and assigning different tasks to the biological registration team. •Supervise and assist the front office team in their performance. •Provides appropriate regulatory advice and support to manufacturers. •Identify areas for improvement within daily functions & procedures, and anticipates new or changing regulatory requirements to improve these processes.
  • Biological Registration specialistFull Time

    Central Administration of Pharmaceutical Affairs

    Jan 2012 - Jan 2014 -2 yrs

    Egypt , Cairo

    • Job Details:•Carrying out the Registration & Re-registration hard files of Vaccines, Sera, Blood Products, Insulin and different Biological Products of all companies in Egypt. •Drug registration hard file recipient reviewer for imported and local biological medicinal products for human use. •Make assessment reports for Biological products submitted for registration. •Follow up the approvals issued from different committees and departments. •Responsible for evaluating registration dossier (Stability, Pricing, Scientific, Pharmacology, Pharmacovigilance center, NORCB). •Preparing data & approvals for the registration dossier that will be submitted to the technical committee. •Prepare the final technical appeal.
  • Biocides Registration specialistFull Time

    Central Administration of Pharmaceutical Affairs

    Sep 2011 - Jan 2012 -4 months

    Egypt , Cairo

    • Job Details:- Biocides registration soft and hard file recipient reviewer for imported and local products. - Make assessment reports for Biocides products submitted for registration. - Follow up the approvals issued from scientific committee & NODCAR. - Preparing data & approvals for the registration dossier that will be submitted to the technical committee.
  • Community PharmacistFull Time

    Ali & Ali pharmacy – Mohandssen Branch

    Sep 2009 - Sep 2011 -2 yrs

    Egypt , Giza

    • Job Details:- Dispensing prescriptions for both in and outpatients. - Compounding pharmaceutical preparations. - Ensure that every customer receive friendly, knowledgeable, and efficient service.
  • Education

    • MBA in Management

      Cairo University (CU)

      Jan 2014 - Jan 2016 - 2 yr

    • Bachelor's Degree in Pharmaceutical Sciences

      Cairo University (CU)

      Jan 2005 - Jan 2009 - 4 yr

    Skills

    Languages

    • Arabic

      Fluent
    • English

      Advanced

    Training & Certifications

    • Project Management Professional (PMP) preparation course

      Al-Darayn Academy·2015
    • ATEFL (Academic Test of English as a Foreign Languauge)

      Cairo University·2014
    • Scientific, Clincal & Regulatory considration on LMWHs, Biological Products & Biosimilars

      ANSM - France·2014
    • Egyptian Biosimilar Guideline workshop

      CAPA Biological department head & NORCB - Cairo·2013
    • Biosimilar workshop

      CAPA Biological department head & NORCB - Cairo·2012
    • Global view of Requirements, Manufacture and Control of Biosimilar products

      ERA Consulting Group - UK·2012
    • CTD format overview & description of different modules

      Science forum for research studies & consultancy - Jordan·2012
    • ICDL

      Ministry of Communications and Information Technology (MCIT)·2010
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