Regulatory Affairs Labeling Director

Reference #: JR5509

SUMMARY/JOB PURPOSE:

Responsible for creating, updating, and maintaining product information and labeling documentation for all relevant Exelixis products across our product portfolio. This position plays an important role in company-wide initiatives around end-to-end labeling and provides dedicated support on Regulatory-related activities and deliverables. This role requires an extensive knowledge of the roles and responsibilities of Regulatory Affairs spanning both clinical and commercial phases of drug development, and how Regulatory Affairs connects with other functional areas. Familiarity with clinical trials (design, results, conduct) is especially important, given the intended cross-functional partnership on clinical trial related activities and Regulatory deliverables. Has experience specifically in the Regulatory Affairs Global Labeling function.