Ksenia Libov

Ksenia Libov has extensive experience in the field of regulatory operations. Ksenia currently holds the position of Director of Regulatory Operations at SpringWorks Therapeutics since November 2023. Prior to this, they served as the Senior Director of Regulatory Operations at FibroGen, Inc. from August 2017 to September 2023, where they led various document and submission publishing activities, including INDs, NDAs, Safety Reports, Protocols, and more.

Before joining FibroGen, Inc., Ksenia worked at Jazz Pharmaceuticals as a Senior Manager, Global Regulatory Operations from July 2012 to August 2017. In this role, they led numerous US and ex-US eCTD submissions and played a key role in BLAs and MAAs publishing activities. Ksenia also championed the preparation and submission of product labeling in Structured Product Labeling (SPL) format.

Prior to their time at Jazz Pharmaceuticals, Ksenia served as a Regulatory Affairs Manager at SciClone Pharmaceuticals, Inc. from August 2008 to July 2012. Ksenia'sresponsibilities in this role included leading regulatory affairs efforts for US submissions and collaborating with Chinese Regulatory CRO for international filings.

Before joining SciClone Pharmaceuticals, Inc., Ksenia worked at Johnson & Johnson as a Sr. Regulatory Affairs Operations Associate from May 2003 to July 2008. In this role, they led complex early-stage and late-stage development eCTD submissions. Ksenia also chaired as the Business Lead for ALZA's first eCTD pilot submission to the FDA.

Earlier in their career, Ksenia held positions at Clinimetrics, Pharmacyclics (an AbbVie Company), and NASA, where they gained valuable experience in project assistance, central records management, and aviation safety reporting, respectively.

Ksenia Libov holds a Bachelor's degree from San Jose State University. Ksenia also attended the University of Technology, where they studied Business & Economics, Physics, Calculus, Chemistry, and Biology.