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Khaled Abdelkader

Senior Regulatory Affairs and Registration Specialist and Freelance Translator

Smouha, Alexandria, Egypt

Work Experience

  • Senior Regulatory Affairs SpecialistFull Time

    Pharco Pharmaceuticals

    Apr 2021 - Present -4 yrs, 3 months

    Egypt , Alexandria

    • Job Details:Registration of new products starting from presubmission till production ( Min .decree 296 , 645 and 425) including CTD and other requirements

  • Regulatory affairs specialistFull Time

    Pharco Pharmaceuticals

    May 2018 - Apr 2021 -2 yrs, 11 months

    Egypt , Alexandria

    • Job Details:Registration of new products starting from presubmission till production ( Min .decree 296 , 645 and 425) including CTD and other requirements

  • R&D and Regulatory affairs specialistFull Time

    Pharco Pharmaceuticals

    Jul 2015 - May 2018 -2 yrs, 10 months

    Egypt , Alexandria

    • Job Details:Preformulation of new products Registration of new products Regulatory affairs

  • Branch managerFull Time

    Seif Pharma

    Aug 2010 - Jul 2015 -4 yrs, 11 months

    Egypt , Alexandria

    • Job Details:Sales follow up and being responsible for every single detail regarding the branch.

    • Education

    • Msc in Microbiology

      High Institute of Public Health

      Jan 2010 - Jan 2015 - 5 yr

    • High School - Thanaweya Amma

      Sidi Gaber Language Schools- Boys

      Jan 2003 

    Skills

    • Internet
    • computer
    • English
    • Regulatory Affairs
    • Microbiology
    • R&D
    • Microsoft Office
    • Pharmacy
    • Management
    • Administration

    Languages

    • Arabic

      Fluent

    • English

      Fluent

    • French

      Beginner

    • German

      Beginner

    Training & Certifications

    • CTD, eCTD and NEES

      Reyada Pro·2018

    • Immediate Release tablet and capsules formulation

      Reyada Pro·2017

    • Q8 Pharmaceutical development

      Amriya Pharm. Ind.·2017

    • Change control

      Pharco pharmaceuticals·2016

    • Awareness ISO 9001/2015

      Pharco pharmaceuticals·2016

    • Orientation about Pharmacovigilance

      European Egyptian Pharm. Ind.·2016

    • Lipid Excipients for Sustained release tablet and bioavailability

      European Egyptian Pharm. Ind.·2016

    • Risk Management

      Pharco pharmaceuticals.·2016

    • How to fill a record

      Pharco pharmaceuticals·2016

    • Microbiology for non microbiologist

      Amriya Pharm. Ind.·2015

    • Fire fighting

      Pharco pharmaceuticals·2015

    • cGMP

      Pharco pharmaceuticals·2015

    • Process validation

      Amriya Pharm. Ind.·2015

    • CPHQ preparatory course

      I learn·2012

    • Clinical practice for pharmacists

      Faculty of pharmacy·2007

    • Production

      Pharonia company·2007

    • Personal Selling

      Arab Academy for Science and Technology·2006
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