Kirk Rosemark

SVP, Regulatory Affairs & Quality Assurance at Xencor

Mr. Rosemark brings to Xencor over 25 years of biopharmaceutical industry experience, leading regulatory affairs and quality assurance organizations, developing and registering products with regulatory authorities and supporting them throughout their lifecycles. Prior to joining Xencor, he most recently served as vice president, regulatory affairs at Beigene (USA), where he developed and evaluated regulatory approval strategies for multiple development projects and combinations thereof and held responsibility for 14 INDs. Before Beigene, Mr. Rosemark was vice president, regulatory affairs and quality assurance at CymaBay Therapeutics, where he led the regulatory strategies for several mid-to-late stage programs, several of which with preferential designations with health authorities. From 2003 to 2014, he was vice president, regulatory affairs and quality assurance at Exelixis, where he led to the regulatory team on the Cometriq® program, taking it from discovery through approvals in the U.S. and EU. Earlier in his career he held roles of increasing responsibility in regulatory affairs at Solvay Pharmaceuticals, Ciba Vision and Bausch & Lomb Pharmaceuticals. Mr. Rosemark received a B.S. in chemistry from Cleveland State University.

Links

Timeline

  • SVP, Regulatory Affairs & Quality Assurance

    Current role

  • VP, Regulatory Affairs & Quality Assurance

View in org chart