Responsibilities

The Associate Director will define commercial regulatory strategies, ensuring all corporate communications adhere to regulatory standards. They will provide regulatory guidance on new marketing concepts and messaging, reviewing and approving all US promotional materials in collaboration with cross-functional teams. The role involves managing the strategy and operational aspects of regulatory labeling for Phase 3 and commercial assets, ensuring accuracy and compliance. Serving as a liaison with the FDA’s promotional review divisions and participating in application labeling negotiations is also a key responsibility. Furthermore, the individual will lead the strategy, coordination, and execution of post-approval regulatory submissions, such as phase 3b/4 studies and amendments, and maintain a strong understanding of FDA regulations and enforcement actions related to pharmaceutical advertising and promotion.