Moheb Helmy
@mohebhelmy
Regulatory affairs specialist with pharmaceutical QA/QC expertise and strong strategic management background.
EgyptWhat I'm looking for
I am a regulatory affairs professional with a pharmacy background and an MBA in Strategic Management, combining technical laboratory experience with regulatory strategy.
I have overseen product registration, prepared export dossiers, and maintained technical files, achieving completion of more than 100 files while working in industry regulatory roles.
My laboratory experience includes quality control, stability inspection, and analytical testing (HPLC, GC, UV, FTIR), ensuring compliance with ICH, GMP, USP and BP standards across public and private organizations.
I bring strong communication, analytical, and organizational skills, proven in roles ranging from raw material analysis and stability inspection to medical data processing and pharmacy practice.
Experience
Work history, roles, and key accomplishments
Regulatory Affairs Specialist
Dr. Fady Pharmacy
Jan 2025 - Present (9 months)
Role currently held; responsibilities not detailed in input.
Regulatory Affairs Senior Specialist
Global Napi Pharmaceuticals
Jun 2022 - Dec 2024 (2 years 6 months)
Managed preparation and submission of export and registration dossiers for new and re-registered products, maintained technical files, and responded to regulatory agency requests; completed over 100 registration files across multiple markets.
Senior Stability Inspector
Egyptian Drug Authority
Apr 2019 - May 2022 (3 years 1 month)
Performed stability lab inspections and document/electronic data reviews to ensure compliance with ICH and GMP, conducted semi-annual and annual equipment and stability cabinet audits, and participated in practical sample analyses.
Medical Data Processor
NEXTCARE Healthcare
May 2018 - Dec 2019 (1 year 7 months)
Processed and validated medical claims data, ensured contract fee accuracy, and maintained high throughput and data quality, achieving up to 700 claims processed per day.
Raw Material Analyst
National Organization for Drug Control
Jun 2018 - Apr 2019 (10 months)
Conducted QC testing of APIs and excipients using USP/BP methods including identification, assay and limits testing to support manufacturing release and compliance.
Pharmacy Staff
El-Sabagh Pharmacy
Jun 2016 - May 2018 (1 year 11 months)
Dispensed prescriptions and OTC medicines, ensured correct dosing and labeling, advised patients on minor ailments and medication interactions, and provided basic health screenings.
Education
Degrees, certifications, and relevant coursework
MUMissouri State University
Professional Diploma in Strategic Management, Strategic Management
2021 - 2021
Completed a Professional Diploma in Strategic Management.
ATArab Academy for Science, Technology, and Maritime Transport
Master of Business Administration, Strategic Management
2018 - 2020
Grade: 3.77 (Excellent)
Completed a Master of Business Administration with a major in Strategic Management and a GPA of 3.77 (Excellent).
GCGerman University in Cairo
Bachelor degree in Pharmacy, Pharmacy
2011 - 2016
Grade: 2.39 (Very Good)
Earned a Bachelor degree in Pharmacy with a GPA of 2.39 (Very Good); completed the 9th semester at the GUC Berlin campus (Sep 2015–Jan 2016).
Availability
Location
EgyptAuthorized to work in
Job categories
Skills
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