DR

Dalya Rizk

Global Regulatory Affairs Associate at Mohammed Alkhuraiji Industrial Company (Apple Pharma)

Egypt

Work Experience

  • Global Regulatory Affairs Associate

    Mohammed Alkhuraiji Industrial Company (Apple Pharma)

    Jan 2023 - Present -2 yrs, 3 months

    Saudi Arabia

    • Job Details:Executing regulatory activities related to registration requirements (new submissions, renewals, products lifecycle maintenance, variations). Responsible for communication and liaison with local/global health authorities (SFDA – GCC health authorities) for all regulatory affairs and registration activities follow-up. Reviewing product promotional materials, labels, batch records, specification sheets, and test methods for compliance with applicable regulations and policies.
  • Global Regulatory Affairs Supervisor

    Middle East Pharmaceutical Industries Co. (Avalon Pharma)

    Dec 2017 - Dec 2022 -5 yrs

    Saudi Arabia

    • Job Details:Preparation, executing and leading regulatory affairs team for all regulatory activities related to registration requirements (new submissions, renewals, products lifecycle maintenance, variations) in body authorities across multiple regions.
  • Regulatory Affairs Unit Head

    Sedico Pharmaceutical Co. (South Egypt Drug Industries Company)

    Jan 2010 - Nov 2017 -7 yrs, 10 months

    Egypt

    • Job Details:Leading regulatory affairs team for preparing and reviewing regulatory submissions in body authorities across multiple regions.
  • Regulatory Affairs Officer

    Sedico Pharmaceutical Co. (South Egypt Drug Industries Company)

    Dec 2002 - Dec 2010 -8 yrs

    Egypt

    • Job Details:Preparing registration dossiers for local and global submissions in body authorities across multiple regions.
  • Education

    • Bachelor's Degree in Pharmaceutical Science

      Zagazig University (ZU)

      Jan 2002 

    Skills

    • Project Management
    • Documentation Management
    • regulatory submissions
    • CMC writing
    • labeling
    • Regulatory Strategy
    • Problem-Solving
    • Communication skills
    • adaptation
    • Negotiation
    View More

    Languages

    • English

      Fluent
    • Arabic

      Fluent
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