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Areas of expertise: Project Management; Strategic Planning, Regulatory Affairs – expertise in pre-INDs, INDs, NDAs, post approvals, DMFs (filing, reporting, and associated processes), Regulatory Operations, SOP Development & Training, Quality Manual
Albert Yehaskel has devoted over 33 years to Regulatory Affairs, and honed his expertise in managing and directing domestic and international Regulatory Submissions, orchestrating key FDA meetings (pre-IND, EOP2, pre-NDA and general guidance meetings) and conducting Pharmaceutical Research and development. He has built and led teams in the filing of two electronic NDAs and several partial NDAs (both 505(b)(1) and 505(b)(2)), scores of INDs in 14 therapeutic areas, has filed several Orphan Drug Designations and interacted with 14 different Divisions at FDA (CDER, CBER, CDRH, OODP); he has also reviewed a plethora of INDs, NDAs, ANDAs, DMFs across the 5 eCTD Modules and has CMC expertise in writing the QOS (Module 2) and Module 3 (Drug Substance, Drug Product).
Albert has worked for Lederle Laboratories (American Cyanamid) now known as Wyeth, Block Drug, Sanofi, Purdue Pharma, Daiichi-Sankyo, Shionogi USA, Inc. and INDIGO. While at Sankyo, he filed and obtained approval of two electronic NDAs whose products (Benicar and Benicar/HCT) he helped launch.
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. He has also provided Regulatory training in the following areas: the NDA, IND and ANDA process, best practices in CMC dossier preparation, communications with FDA, assembling a Quality Manual, best practices for an Investigator’s Meeting and Global Development Plans.
Albert provides Kinexum with an in-depth experience and expertise into managing all phases of regulatory projects with a focus on client needs.
Albert received his BS degree from the Polytechnic Institute of Brooklyn, his MS degree from Queens College, City University of New York and his MBA from Fairleigh Dickinson University with a concentration in economics and finance.