Jay Jariwala U.S. FDA

Jay Jariwala is a Team Leader with the Office of Manufacturing Quality, Office of Compliance, CDER, where he provides leadership and operational oversight of compliance officers assessing violative establishment inspections and resulting regulatory actions. During his tenure he spearheaded numerous regulatory actions such as injunctions, warning letters, regulatory meetings, and import alerts.  He also participates in inspections as a Subject Matter Expert. He was instrumental in developing various risk-based assessment processes including Warning Letter review procedure. He also represented CDER in Mutual Reliance Agreement Initiative in assessing various EU drug inspectorates’ capabilities. Due to his multi-center background, he was a member of the group instrumental in developing CGMPs for Combination Products, resulting FDA guidance, and investigator training.

Previously, he served as an Assistant Country Director with FDA’s India Office from 2017 to 2019.where he managed establishment inspections, advised FDA leadership on drug policy issues, and collaborated with various governmental, internal, and industry stakeholders.

He began his FDA career in 2008 in CDRH, where he spent 7 years in Office of Compliance and held positions of increasing responsibilities starting as a compliance officer to a quality system specialist, and was part of Medical Device Single Audit Program (MDSAP) team.