Lead, Regulatory Affairs Advertising & Promotions

Purpose & Scope: The purpose of this position is to provide direction and accountability for the regulatory review of advertising and promotional materials for the Astellas portfolio of products in the US in compliance with the requirements set forth by FDA. Essential Job Responsibilities: - Provides regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies, complex issues that influence the success and compliance of advertising and promotional labeling generated by Astellas, and relevant company materials for unapproved products/indications under development. The position will have direct impact on the advertising and promotional materials (hundreds annually) across Astellas brands and health systems areas in the US. Organizational Context: Position will report to the Senior Director responsible for promotion review within US Regulatory Affairs and manage one or more direct reports at the associate director, manager or associate levels. This position will support organizational initiatives within RA as well as with stakeholders external to RA.