JAY JARIWALA is the senior director of regulatory compliance with a focus on pharmaceutical quality system compliance and enforcement matters. Prior to joining Sidley, Jay served as team leader/Combination Products subject matter expert within the Office of Compliance at the Center for Drug Evaluation and Research (CDER), a branch of the U.S. Food and Drug Administration (FDA).
For over 13 years, Jay served as an FDA regulator at multiple FDA centers, including CDER, the Center for Devices and Radiological Health (CDRH), and the Office of the Commissioner, applying the agency’s laws, regulations, guidance, and other technical and administrative policies on drugs, medical devices, and combination products to policy development, facility inspections, compliance, enforcement, and approval processes. His FDA leadership experience includes serving as assistant country director (Drugs) and supervisory Consumer Safety officer in the agency’s India Office (New Delhi). Jay also participated as a subject matter expert in many drug inspections with a focus on data integrity and Out-of-Specification (OOS) investigations.
Before shifting his FDA focus to drugs, Jay spent several years at CDRH working on compliance issues related to medical devices, including regulatory policy related to Quality System Regulation and advisory actions. During his time at CDRH, he held positions of increasing responsibility, including the role of Quality System Specialist, and worked with several international regulators to establish the Medical Device Single Audit Program.
As team leader / Combination Products subject matter expert, Jay led a large team of compliance officers within the Division of Drug Quality I, the Office of Manufacturing Quality (OMQ), the Office of Compliance, and the CDER. In addition to his responsibilities for resource planning and operational oversight for violative establishment inspection assessments and resulting regulatory actions, Jay trained FDA investigators on current good manufacturing practice (CGMP) requirements — particularly data integrity and quality investigations. In New Delhi, Jay managed a team of investigators for all facility inspections conducted by the India Office and compliance follow-up. He also liaised with foreign regulatory counterparts such as EU/EMA, EDQM, PMDA-Japan, and WHO to establish inspection synergies and the exchange of information. During his time, he spearheaded many advisory and administrative actions, such as Warning Letters, Import Alerts, Regulatory Meetings, Recalls, and Injunctions.
Due to his background in drug and medical devices, Jay was part of the FDA group responsible for developing CGMPs for combination products, guidance, internal training, and a compliance program. In OMQ, Jay advised on and assisted compliance officers and leadership in evaluating policies, inspectional matters, and resulting regulatory actions related to combination products.
A noted speaker on a broad variety of topics including facility inspections, data integrity, OOS investigations, quality culture, supply chain integrity, corrective and preventive actions, and globalization and compliance trends, Jay also holds several medical device- and drug-related teaching roles. He earned a bachelor’s degree in Mechanical Engineering from the National Institute of Technology in Surat, India, and a master’s degree in Mechanical Engineering from Kansas State University.
*Not admitted to practice law.