Jay Jariwala is an Assistant Country Director with FDA’s India Office. His primary role is to advise FDA leadership on drug policy issues as it concerns India and collaborate with various internal and external stakeholders to advance FDA’s strategic priorities in India. He is also currently acting as Supervisory Consumer Safety Officer managing all inspections conducted by the India Office. Prior to joining FDA’s India Office, He was a Team Leader in the Office of Manufacturing Quality, Office of Compliance, CDER, where he provided 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 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 currently being utilized. He also represented CDER in Mutual Reliance Initiative in assessing various EU drug inspectorates’ capabilities.
Prior to joining CDER, He spent 7 years in CDRH Office of Compliance where he held positions of increasing responsibilities starting as a compliance officer to a quality system specialist. While at CDRH, he was part of Medical Device Single Audit Program (MDSAP) team which is a collaborative inspection effort between US FDA, Health Canada, Therapeutic Goods Administration of Australia, and ANVISA Brazil. Due to his multi-commodity and multi-center background, he was member of a core group instrumental in developing CGMPs for Combination Products, resulting FDA guidance, and investigator training. He was selected and successfully completed CDER’s Emerging Leader Program (ELP.) He has regularly spoken at various conferences and taught various CGMP related courses on behalf of the Agency.
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