Associate Director, Regulatory Affairs Advertising & Promotion

Responsible for performing regulatory review of advertising and promotional materials for Astellas in the US. Responsible for the training of regulatory staff, as required. Establishes effective working relationships and collaborates with cross-functional review team members representing internal functions and external business partners. • Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that contents of promotional and sales training materials are consistent with the current approved US Prescribing Information and advises Regulatory Operations group regarding requirements for FDA 2253 submissions. The position has impact on regulatory compliance of commercialized products in the Americas as well as some activities associated with non-promotional external communications in the US for projects in development.