YH
Yasmine Hashem
Regulatory Affairs Section Head at HPG company
Cairo, EgyptWork Experience
Regulatory Affairs PharmacistFull Time
- Job Details:-Establishing food supplement sector Reviewing food supplement dossiers for submission & following up with the National Food Safety Authority (NFSA) in Egypt, submitting appeals & attending meetings Dealing with agents abroad providing them with the most updated data regarding the registration guidelines in Egypt Coordinating with various company's departments Responsible for the Research and Development of food supplement products, searching for new moieties to be registered and creating formulas Contacting factories for contracts & raw material suppliers
Regulatory Affairs Section HeadFull Time
HPG company
Nov 2019 - Present -5 yrs, 8 months
Egypt , Cairo
- Job Details:Deputy Manager; assure timely submission of technical documents to the MOH, supervise a team of 5. -Resolve internal & external issues. -Reviewing food supplement, cosmetic & pharmaceutical products' dossiers for submission & following up with the National Food Safety Authority in Egypt (NFSA), the Egyptian Drug Authority (EDA) & the National Nutrition Institution (NNI). -Preparing & reviewing stability files, box inquiries, cosmetic files, pricing appeals & biological files. -Representing the company at the pricing committee & meetings with NFSA upper management. -Dealing with agents abroad providing them with the most updated data regarding the registration guidelines in Egypt. -Coordinating with various company's departments. -Dealing with inspections & inspectors. -Representing the company at NFSA, NNI & EDA.
Regulatory Affairs SeniorFull Time
Central Administration for Pharmaceutical Affairs
Mar 2011 - Oct 2019 -8 yrs, 7 months
Egypt , Cairo
- Job Details:Assessing companies’ applications submitted for drug product registration in the Boxes team. -Reviewing drug product dossiers according to the ministerial decrees 296, 645 & 370 in the Hard files team. -Communicating with different companies via the reception & emails. -Communicating with the various CAPA departments. -Issuing approvals for pharmaceutical products
Education
Bachelor's Degree in Pharmaceutical sciences
Ain Shams University (ASU)Jan 2009
Skills
Languages
English
Fluent