Regulatory Affairs Professional with accumulated (RA/Quality) pharmaceutical experience

I am working in the field of Pharmaceutical Industries; I am a pharmacist; I am about 16 years real-time; accumulated expert in Regulatory Affairs, Quality Control & Methodology in the Pharmaceutical field. I am dealing with awareness with WHO, ICH, FDA, Eudralex, EMEA, OMCL & ISO 17025 guidelines through real inspection audits from WHO, FDA, EMEA, DNDI, ISO 17025 & others. Also, I performed GMP audits for API (ICH Q7 guideline) & Packaging manufacturers in China, India & Malaysia; pre-inspection for pharmaceutical finished products as Thornton & Ross LTD/UK as well. I am Analytical &Technical affairs responsible for ISO 17025 team and one of the teams responsible for being accredited for ISO 17025 by EGAC & Participating in many projects in it.
I have 16 years’ experience in Quality, including experience in registration, regulatory affairs for exportation, by preparing CTD, NeeS & e-CTD (EXTEDO V.4) registration, renewal dossiers & launching of pharmaceutical products/Cosmetics/MD/OTC/GSL/specialties, as to be registered in many countries (MENA, Levant, CIS Region, African Countries, Gulf Region, Asian Countries (ACTD), APAC & WHO dossiers) according to the guidelines of each country (for ex.; WHO, GCC, Bahrain, Kuwait, Qatar, Lebanon, Jordan, Morocco, Uganda, Sudan, Nigeria, Iraq, Azerbaijan, Croatia…). Able to challenge health authorities for critical issues and regulatory intelligence implementation.
I have a personal mission which is to continue developing myself to be able to add value to my workplace. I am MBA holder; I am Certified Six Sigma Green belt (CSSGB) by IQF in USA. I also completed the course & exam for Total Quality Management (TQM-P) and completed the course for PMP (PMBOK V.5). I am VETASSESS accredited for Quality as a pharmacist and in the Pharmaceutical field. I am highly organized with excellent analytical thinking and problem-solving skills, I am self-confident with strong capability to work under pressure, excellent co-ordination.

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