Omar Bakhsh

Regulatory and Corporate Affairs Director at Alrajhi Pharma - الراجحي الدوائية
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Contact Information
us****@****om
(386) 825-5501
Location
Saudi Arabia, SA

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5.0

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Rawan Alkhalaf

I had the pleasure to work with Omar in SAJA Pharmaceutical. He demonstrated a strong work ethic and comprehensive knowledge and experience in the field of regulatory affairs. Omar is a person with exceptional character with a positive attitude and willingness to help others. Any organisation would be fortunate to have him on their regulatory team.

Ahmed Mohammed, PhD researcher, TechIOSH

Dr.Omar is very good person in drug registeration work , he is an ambitious person , a reliable and sophisticated.

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Experience

    • Saudi Arabia
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory and Corporate Affairs Director
      • Jun 2021 - Present

      Key Responsibilities: Fulfillment SIDF requirements for loan application, and loan granting Team member for establishing company manufacturing site at KAEC Team member for building company strategy, vision and mission Team member for creation company’s product portfolio Building regulatory and quality department Key Responsibilities: Fulfillment SIDF requirements for loan application, and loan granting Team member for establishing company manufacturing site at KAEC Team member for building company strategy, vision and mission Team member for creation company’s product portfolio Building regulatory and quality department

    • Saudi Arabia
    • Pharmaceutical Manufacturing
    • 400 - 500 Employee
    • Scientific Office Manager
      • Sep 2016 - Sep 2020

      Key Achievements: Collaborating with regulatory team to successfully achieve the submission and registration of 31 products (59 SKUs) at SFDA Lead 2D barcode with serialization project up to level 3 aggregation and link it with SFDA portal “RSD” Team member in winning NUPCO tender awardation task for “fingolimod” by 100% replacing the innovative. Creation department SOPs and WIs Key Achievements: Collaborating with regulatory team to successfully achieve the submission and registration of 31 products (59 SKUs) at SFDA Lead 2D barcode with serialization project up to level 3 aggregation and link it with SFDA portal “RSD” Team member in winning NUPCO tender awardation task for “fingolimod” by 100% replacing the innovative. Creation department SOPs and WIs

    • Germany
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Regulatory Affairs Director - GCC Region
      • Feb 2011 - Jul 2016

      Key Achievements: Team member in achieving “Glucophage localization project” in Saudi Arabia and Gulf Countries Implementing 2D Barcode with serialization for all registered products. Team member in achieving “Cut Complexity” project across the region. Team member in validating and maintaining the new internal digital systems for regulatory archiving and activities. Establishing regulatory development in Saudi Arabia (Budget, SOPs, Archiving) Team member for launching “Training Program for Pharmacy Graduates” in KSA Show less

    • Saudi Arabia
    • Pharmaceutical Manufacturing
    • 400 - 500 Employee
    • Registration and Site Technical Manager
      • Jan 2008 - Jan 2011

      Key Achievements:Maintaining GMP certificate at Health Authority in Saudi Arabia, Gulf, Levant, and North Africa region.Registering SAJA site in Levant and North Africa region.Establishing registration department (SOP, Policy, Workflow) and achieve publishing and registering SAJA products in Saudi Arabia, Gulf, Levant and North Africa Health Authorities

    • Quality Control / Quality Assurance Officer
      • Oct 2005 - Dec 2007

    • Pharmacy Manager
      • Feb 2005 - Sep 2005

    • Saudi Arabia
    • Hospitals and Health Care
    • 700 & Above Employee
    • Out-patients Pharmacist
      • Feb 2003 - Dec 2004

Education

  • King Saud University
    Bachelor, Pharmacy
    1997 - 2002

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