Aalaa Mohamed Okasha

Senior regulatory specialist at Soficopharm Pharmaceuticals S.A.E

Maadi, Cairo, Egypt

Soficopharm Pharmaceuticals S.A.E

Mar 2020 - Present -5 yrs, 4 months

Egypt , Cairo

Job Details:Perform all activities pertaining to imported Pharmaceuticals, Medical Devices, Cosmetics and disinfectants registrations/re-registration at the EDA (Egyptian Drug Authority) including all activities involved with currently registered product variations. 1.Registration of food supplements, infant formulas & athletes supplements at NFSA (National food Safety Authority) and follow through all analysis and release procedures. 2.Following up all stages of registration with the competent governmental authorities until the obtaining of registration licenses. 3.Ensure full compliance to the national regulations in terms of registration, inspections & release

WIS pharm for Export and Import

Aug 2018 - Feb 2020 -1 yr, 6 months

Egypt , Cairo

Job Details:1.Ensure full Regulatory Compliance to the EDA both regulatory & vigilance rules & regulations. 2.Perform all regulatory activities necessary for registration of new & re-registration of medical devices. 3.Perform all activities related to products quality (vigilance) both preregistration & post registration including construction of vigilance SOP’s, compliant handling & recalls and 4.Coordinating Post Market Surveillance activities, such as FSCA/FSN notifications and vigilance activities where applicable 5.Fulfill the importation requirements to secure imports permission and shipments clearance (release). 6.Medical release procedures including the preparation of medical devices release dossiers & sampling history via related documentation for the inspector review on the preset inspection date based on which the inspector should decide whether to do sampling, partial or complete release. Follow up with NODCAR until Certificate of Conformity issuance for inspector review & final release

Master's Degree in business
Arab Academy for Science, Technology and Maritime Transport (AAST)
Jan 2013