Senior Director, Regulatory Affairs – Infectious Disease

Role: Senior Director of Regulatory Affairs for Infectious Disease biologics and vaccines, providing strategic leadership from early development through initial registration. Responsibilities: develop and execute global regulatory strategies, lead regulatory submissions (INDs, amendments, marketing applications), serve as primary agency contact, lead regulatory interactions with FDA and other authorities, oversee lifecycle management, and collaborate cross-functionally across clinical, nonclinical, CMC, and commercial teams. Requirements: Bachelor's in biological or pharmaceutical sciences; 12+ years in regulatory affairs with experience leading global strategies for vaccine or infectious disease biologics; proven success in guiding programs from early development to regulatory approval; extensive experience with FDA and global regulatory agencies; strong leadership and communication skills; ability to manage multiple initiatives in a fast-paced environment. HighValue: biologics, infectious disease, vaccines, prophylactic or therapeutic biologics, Phase 2 development, global regulatory strategy, FDA interactions, lifecycle management, cross-disciplinary leadership. WorkSetup: not specified, travel up to 20%.