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Christopher Joneckis, PhD

Associate Director For Review Management/ Director Office of regulatory Operations, CBER
US FDA

Chris Joneckis, Ph.D., serves as the Associate Director for Review Management and Director, Office of Regulatory Operations for the Center For Biologics Evaluation and Research (CBER) at FDA. In this capacity, he Is the Center’s authoritative lead on regulatory operations including review management, and providing leadership for review program activities executed throughout the offices of CBER. He has a principal role in user fee negotiations. He is responsible for the development, implementation and oversight of several CBER programs including; procedures and standards for review, data standards, information technology, regulatory affairs, document control, regulatory data and database, regulatory business operations and Chemistry Manufacturing and Controls and Deivce policy.

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