Kate L.

Virology

Liver disease

• Lead development of world-wide clinical trial applications (US, EU, China, Australia) for several first in human studies oncology studies • Develop and present regulatory strategy assessments and recommendations to senior leadership • Remain updated on regulatory and competitive landscape

• Work directly with Head of Regulatory Affairs to manage complex regulatory projects • Manage Advisory Committee Meeting preparation sessions, coordinate responses to FDA information requests, and support several FDA meetings during NDA review • Provide oversight for strategic development and review of documents, and oversee cross-functional sub-team meetings and regulatory deliverables to ensure timely submission of MAA to EMA

• Support several hematology programs in different stages of development, including IND/NDA/BLA submissions • Support Health Authority meeting activities for multiple teams including compiling of meeting requests and briefing packages as well as coordinating meeting logistics with stakeholders • Participate in Regulatory Affairs Functional Teams; lead and contribute to team discussions, manage meeting agendas and minutes • Represent regulatory affairs at cross-functional meetings and provide regulatory insight for global clinical studies • Manage routine submissions for IND maintenance, such responses to FDA information requests, Protocol Amendments, Investigator Packages, Investigator Brochures, and DSURs • Conduct regulatory research and create regulatory intelligence briefings and presentations to inform regulatory strategy

I studied the role of ubiquitin ligases in DNA damage in mammalian cells in the lab of Dr. Dave Toczyski

I studied DNA damage signaling and repair in the C. elegans germ line in JoAnne Engebrecht's lab

I studied DNA damage signaling and repair in the C. elegans germ line in JoAnne Engebrecht's lab