Sidley is pleased to welcome Jay Jariwala, Senior Director, Regulatory Compliance, to the firm’s Food, Drug, and Medical Device Compliance and Enforcement practice. He joins the firm’s Washington, D.C. office from the U.S. Food and Drug Administration (FDA), where he served most recently as Team Leader/Combination Products subject matter expert in the agency’s Center for Drug Evaluation and Research, Office of Compliance, Office of Manufacturing Quality (CDER/OMQ). Jay will rely upon his more than 13 years of agency experience to help the firm’s life sciences clients—including drug, biologics, and medical device manufacturers—prepare for regulatory inspections, address regulatory inspection observations, assist in developing and executing remediation plans, respond to FDA compliance and enforcement actions, and provide guidance on interactions with the FDA.
Jay’s comprehensive background as an FDA regulator includes multi-center (CDER, CDRH, and Office of the Commissioner) as well as multi-modality (drugs, medical devices, and combination products) experience applying the agency’s laws, regulations, guidance, and other technical and administrative policies to policy development, investigation, compliance, enforcement, and approval processes. In addition to his role in CDER/OMQ, his FDA leadership experience includes serving overseas as the Assistant Country Director (Drugs) to the Agency’s India Office in New Delhi, India.
“We’re happy to welcome Jay to our growing team of former FDA officials who have world-class experience and insights. Jay’s background will strengthen our team’s ability to help clients understand, assess, and address compliance concerns effectively,” said Raj Pai, partner and global leader of Sidley’s Food, Drug, and Medical Device Compliance and Enforcement group.
As a Team Leader/Combination Products subject matter expert in CDER/OMQ, Jay led a team of compliance officers within the Global Compliance Branch 3 of the Division of Drug Quality I. In addition to his responsibilities for oversight of violative establishment inspection assessments and resulting regulatory actions, Jay trained FDA compliance officers and investigators on Current Good Manufacturing Practices (CGMP) requirements—including data integrity and quality investigations. In New Delhi, Jay managed a team of investigators for all inspections conducted by the FDA’s India Office—planning, execution, risk-based evaluation, and regulatory action recommendations—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. Jay also participated in complex inspections with a focus on data integrity and OOS investigations.
Due to his background in drugs and medical devices, Jay was part of the Agency’s group responsible for developing CGMPs for Combination Products, guidance, FDA’s internal training, and compliance program. In OMQ, Jay advised and assisted compliance officers and leadership to evaluate combination products related policies, inspectional matters, and resulting regulatory actions.
Prior to his work in CDER/OMQ, Jay served as a compliance officer in CDRH handling, among other things, Quality System Regulation compliance reviews of domestic and international device manufacturers and related administrative and regulatory actions, including Untitled Letters, Warning Letters, Seizures, and Injunctions.