Senior Regulatory Affairs Manager - Submissions & Strategy

ADMA Biologics in Boca Raton, FL, seeks a Manager of Regulatory Affairs to lead regulatory strategy and submission activities onsite. This role requires coordinating with multiple departments, preparing IND/BLA submissions, and ensuring compliance with FDA regulations throughout development and post-approval stages.

The candidate will manage timelines, collaborate with QA, and drive process improvements to enhance submission quality and efficiency.