Regulatory Affairs/Intelligence (Pharma/Consumer Health/MD)-(MEA/LEVANT/APAC/CIS/Others). Regulatory End to End consultation service.
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, presentation & communication skills and very good team-work player, capable of thinking outside the box and always come up with creative ideas and ability to learn fast.
I am currently working for STADA Group. I have diverse experience in Regulatory affairs; working for many regions (MENA/Levant/Africa/CIS/APAC); having also accumulated good technical background helping to think out of the box for seeking Health authorities approvals and assuring quality of dossiers and diverse communication in many directions.
Here is a great success, I have achieved, regarding my portfolios (Pharma/Cosumer health/OTC/MD/ Specialities) in the MENA/Levant, during these two years 2019/2020 in STADA summarized mainly as:
1. 2019 new applications approvals: 51 SKUs
2. 2020 new applications submissions: 88 SKUs
3. 2020 new applications approvals: 50 SKUs