About me
Aspiring to Regulatory affairs in Pharmaceuticals
/ Pharmacovigilance
Languages: English language skills
( IELTS ACADEMIC - CEFR B2 Level )
Experience in GMP environment as working in Quality Assurance as a QA Specialist IPC
Background : B.Pharm ( Bachelor of Pharmacy ) from German University in Cairo GUC - Egypt
Hussein Hassaballah
My Linkedin profile
Ready to relocate to UAE, Dubai
In the 1st of December 2025
PROFESSIONAL CERTIFICATIONS & ACHIEVEMENTS:
o Gaining a strong foundation in the CTD/eCTD format, content of clinical sections in NDA, BLA in US, and MAA in EU submissions, and global FDA regulatory frameworks.
o Trained in preparing and reviewing regulatory documents across clinical, non-clinical, and quality modules (1–5), compliance with ICH guidelines
· Intermediate medical writing: Pharmaceutical and Biologics - (3 RAC Points)
JOHN HOPKINS UNIVERSITY
July 2025
Drug Safety: Pharmacovigilance
Regulatory affairs professional society ( RAPS )
October 2025
o Key concepts in ICSR processing (MedDRA, causality assessment, seriousness assessment, Argus), signal detection, FDA safety frameworks, post marketing case studies, and aggregate reporting basics of PSUR and PBRER
· Six Sigma - Define and Measure Course
Technical University München TUM - EDX
May 2023
o Key Concepts in Quality Assurance TQM, GMP, SOPs, Impact of Defects Measuring Defect, Supply Issues, CAPA, FMEA, HSE, Risk management
