Mirna Rizkallah

Experience

• 

  EVA pharma

  Sept 2019 - Aug 2020

  Document Control and Regulatory Compliance Specialist

  * Coordinate and prepare regulatory submissions for finished products and raw materials at NODCAR and CAPA.* Manage the final product and Raw Material submissions to regulatory authorities to obtain timely product approvals* Coordinate with MOH inspector visits and prepare all the relevant needed documents.* Keep both manual and automated for documentation systems are within GMP and ISO guidelines* Maintain the processes for the development, approval, and release of product specifications and procedures, quality system process documentation and environmental management system documentation.* Participate in the preparation of master documents e.g. Site master file, validation master plan and company manuals.* Maintain and update an efficient documentation control system.* Archive and retrieve quality records assigned to the Document Control, including external standards, technical reports, etc.* Check and submit all corporate documents to relevant departments on time.* Follow up document control systems in company in terms of issuing documents, submitting, canceling, and maintaining all master documents.* Review production batch record, packaging and raw materials analysis records according to GMP regulations for final release Show less

• 

  GSK

  Sept 2020 - Jan 2024

  French west and central Africa - Senior Submission delivery specialist (Assembly & Publishing eCTD files ) in GCC and Europe- Supporting Local regulatory affairs team- Preparation of SPC, PIL, Artwork, Comparison tables and all labelling related documents in GCC markets and French Speaking countries- Support Regional projects team for market authorization transfer.- Preparation of Local Market Specific Requirements documents in GCC and French speaking countries (French West and Central Africa)

  • Regulatory Affairs Executive, Africa Cluster

    Sept 2023 - Jan 2024

  • Senior Global Regulatory Affairs Specialist

    Dec 2022 - Aug 2023

  • Global Regulatory Affairs Specialist

    Sept 2020 - Dec 2022
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  Abbott Nutrition NL

  Feb 2024 - now

  Regulatory Affairs Associate Manager

  Regulatory Affairs Associate Manager for Egypt, LEVANT and Africa regions, responsible for all regulatory affairs work, new submissions, renewals, label development, licenses followup, regulations followup, coordination with third parties, and dealing with health and Food authorities across the region.