Director/Senior Director, Regulatory Affairs Advertising and Promotion

This role will be responsible for review and approval of U.S. promotional and non-promotional materials and will serve as the... primary liaison to FDA Office of Product and Drug Promotion (OPDP). Reporting to the Head of Regulatory Affairs, this role will lead the development of processes and policies and establish commercial regulatory infrastructure in support of Kura’s evolution into a commercial organization. This role requires a deep understanding of industry regulations, excellent leadership skills and the ability to work cross functionally to drive regulatory strategies. • Collaborate with colleagues in Commercial, Medical Affairs, Legal, and Compliance to incorporate regulatory considerations into promotional and non-promotional materials, including the creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange. • Advanced experience with promotional and medical review supporting product communications, liaising with FDA (OPDP) on advertising and promotion matters, and managing regulatory submissions of promotional materials for marketed prescription drug products.