Magda A.
Senior Regulatory Affairs Specialist
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Magda A. is a seasoned Regulatory Affairs Senior Specialist with extensive experience in the pharmaceutical industry, focusing on the GCC region and Egypt. With a distinguished career at IQVIA and Sanofi, she has excelled in preparing and revising regulatory submissions, driving lifecycle management activities, and ensuring compliance with evolving health authority standards. Her adept handling of CTD (Common Technical Document) files and managing dossier compilation demonstrate her strong competency in regulatory processes. At Utopia Pharmaceuticals, Multi-trade for Trading Company, and Egypharma Group, she led regulatory documentation, maintained databases, and ensured alignment with compliance standards using tools such as Veeva Vault. Magda's ability to coordinate with cross-functional teams and regulatory authorities marks her as a pivotal player in seeking timely approvals and maintaining product compliance. Her academic background from Misr International University, enhanced by workshops and training in regulatory affairs, underpins her compliance management expertise and strategic input in regulatory impact assessments.
Experience
Regulatory Affairs Senior Specialist
IQVIA · 2025 — PresentPrepare and revise regulatory submissions within the GCC and Egypt, ensuring compliance with evolving health authority standards. Conduct regulatory impact assessments for product changes and manage lifecycle activities, including labeling updates and post-approval submissions.Regulatory Affairs Senior Specialist
Sanofi · 2023 — 2024Facilitate regulatory submissions in the GCC region and Egypt, handling dossier compilation and submission for new registrations. Review CTD files for accuracy and compliance, customizing Module 1 documentation to meet specific health authority requirements.Regulatory Affairs Section Head
Utopia Pharmaceuticals · 2020 — 2023Lead regulatory submissions for pharmaceutical and biological products, reviewing CMC documentation and CTD files to ensure compliance. Manage dossier preparation and submissions via Veeva Vault, tracking registration records and regulatory timelines.Regulatory Affairs Section Head
Multi-trade for Trading Company · 2019 — 2020Oversee regulatory activities across multiple toll companies. Develop and maintain a database for product statuses and submission deadlines. Review regulatory documents and handle pricing appeals and license renewals.Regulatory Affairs Section Head
Egypharma Group · 2018 — 2019Manage new generic product registrations, aligning submissions with regulatory guidelines. Coordinate communication among multiple departments to achieve regulatory objectives.Regulatory Affairs Specialist
Egypharma Group · 2016 — 2018Update databases to track product approvals and submission statuses. Identify process improvements for regulatory operations, liaising with CAPA departments to resolve inspection and compliance issues.Regulatory Affairs Specialist
Central Administration for Pharmaceutical Affairs · 2014 — 2016Perform regulatory operations for pharmaceutical companies, preparing registrations for new generic products and managing submissions for medical devices. Ensure adherence to industry regulations and maintain effective communication with stakeholders.Registration Department
Central Administration for Pharmaceutical Affairs · 2013 — 2014Track product statuses, coordinate with departments on submissions, and manage registration for biocides and antiseptic products. Organize departmental work to ensure compliance with new guidelines and technical committee decisions.
Skills & Expertise
Education
- Bachelor's Degree in Pharmaceutical SciencesMisr International University · — — 2012
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