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Katy Rudnick

Vice President and Head of US Regulatory Affairs

Katy has 20 years of regulatory and quality experience in the US market, is highly experienced in managing business-critical projects with proven first cycle application approvals and possesses a well-rounded perspective of the global drug development market having worked in all therapeutic areas and dosage forms.

A specialist in Regulatory Affairs strategy, and project pipeline and portfolio development and implementation of process flow standardization and efficiencies, Katy has experience with integration activities and special business partnerships.

She has a Masters in RA/QA from Temple University, Philadelphia, PA, and is currently one of an elite cohort of students accepted into the regulatory doctorate program at the University of Southern California, Los Angeles.

Before joining Boyds, Katy was Director, Regulatory Affairs at Lupin Pharmaceuticals, Inc., with responsibility for circa 400 products at various stages (mainly ANDAs with several BLA/NDAs), the company’s early-stage regulatory strategy, and for coordination with R&D assuring acceptable filing of original applications. She also led Lupin’s liaison with the FDA, internal and external due diligence,  and risk/benefit assessment strategies.  She has also previously led a successful regulatory operations team for dossier publishing.

Formerly, Katy has held senior RA roles including as Manager, Regulatory Affairs Pre-Approval Group Leader at Lannett Company, Inc.; Regulatory Affairs Associate II for Teva Pharmaceuticals USA; and Quality Control Laboratory Supervisor in the R&D department of Mars Fishcare North America, Inc.

As Boyds’ VP and Head of US Regulatory Affairs, Katy effectively utilizes her knowledge of the global pharmaceutical industry to support our US-based clients and facilitate our many interactions with the FDA.