Reem Mamdouh

Manage end-to-end preparation, review, and coordination of CTD/eCTD regulatory submissions for human pharmaceutical products, focusing on oncology. Achieved 100% on-time submissions to the Egyptian Drug Authority and coordinated cross-functional efforts to resolve compliance issues.

Supported pharmaceutical regulatory activities and submissions, gaining hands-on experience with documentation and product registration. Collaborated with regulatory team members to prepare compliant and timely submissions.

Provided medication dispensing, counseling, and patient education for 60-70 patients daily in a Ministry of Health-affiliated outpatient medical center. Led a high-performing immunology-dermatology team of 20 employees, including 5 direct reports.

Supported large-scale public health and immunization initiatives through patient education and vaccine administration support. Maintained adherence to vaccine handling and storage requirements.

Completed GDP Training in 2026.

Completed eCTD Publishing & Submission Training in 2026.

Completed Pharmacovigilance Training and GDP Training in 2026.

Earned a Project Management Professional (PMP) Diploma in 2025.

Earned a GMP Diploma in 2025.

Completed GCC Consultant Regulatory Affairs in 2025.

Completed Regulatory Affairs & CTD/eCTD Dossier Preparation in 2025.

Completed FDA Drug Labeling training in 2025.

Bachelor of Pharmacy degree from Cairo University.

Completed Data Analysis course on Coursera in 2026.

Completed Pharmaceuticals: Definition and Lifecycle in 2026.

Completed Introduction to Regulatory Affairs in the US and Canada and Pharmaceuticals: Definition and Lifecycle in 2026.