Albert Yehaskel

Albert Yehaskel is an independent consultant who has over 45 years of experience in the Pharmaceutical industry.  He is an experienced and accomplished pharmaceutical professional with a distinguished record of achievement and success in the management of regulatory affairs.

He has worked for Lederle Laboratories (American Cyanamid) as an international CMC regulator and, Block Drug, Sanofi, Purdue Pharma, Daiichi-Sankyo, Shionogi USA, Inc. and INDIGO Pharmaceuticals from pre-IND to post-NDA holding high level regulatory positons from senior director to VP positions.  In 2010, Albert began to consult, where his expertise encompasses drugs, biologics and medical devices. His early career was devoted to medicinal pharmaceutical research and development in the areas of antibiotics and CNS agents.

During his regulatory career he authored, managed and directed all types of domestic and international regulatory submissions. Albert has filed and obtained approval of two electronic NDAs whose products are currently on the market. He is also well versed in the area of eCTD, having written many CMC sections in Modules 2 and 3. He has also filed numerous IND applications, amendments, supplements, Special Protocol Amendments, Labeling and other Regulatory documents with FDA.

Albert has had direct experience with over 14 different divisions at FDA (CDER, CBER, CDRH), preparing briefing documents, engaging in preparatory rehearsals and subsequently orchestrating key FDA meeting. He has successfully negotiated with FDA in the areas of stability, labeling and the Carcinogenicity Assessment Committee (CAC). Albert has built, managed and mentored regulatory teams as well as creating regulatory and quality infrastructures in companies that did not have any. He has written many SOPs and provided in-house training.

Albert earned two Master degrees; a Master of Business degree in Economics and Finance from Fairleigh Dickinson University and a Master of Science degree in Organic Chemistry from Queens College, City University of New York.  His Bachelor of Science degree in Chemistry was earned at the Polytechnic Institute of Brooklyn. He also served as an undergraduate instructor while pursuing his Master of Science degree, most recently taught several Regulatory Affairs modules at Stony Brook and teaches a CMC course for DIA on an annual basis.

Courses Taught