Senior Director, Regulatory Affairs – Infectious Disease

Role:
Senior Director, Regulatory Affairs for Infectious Disease at Tonix Pharmaceuticals, leading global strategic regulatory activities for biologics and vaccine programs from early development through registration.
Responsibilities: develop and execute regulatory strategies across nonclinical, CMC, clinical, and post-marketing phases; lead preparation of submissions, manage interactions with FDA and global authorities, guide lifecycle management, and oversee compliance with global regulations and standards; collaborate with cross-functional teams including clinical, CMC, nonclinical, medical affairs, and external partners.
Requirements:
Bachelor's in biological or pharmaceutical sciences; 12+ years of regulatory experience, notably in vaccine or infectious disease biologics; proven leadership as a Global Regulatory Lead; extensive experience with INDs, CTAs, agency interactions, and global regulations (FDA, ICH, EU).
Preferred: advanced scientific degree, experience guiding programs from early phases to marketing approval, and mentoring regulatory teams.
High Value: focus on prophylactic or therapeutic vaccines, infectious disease biologics, Phase 2 development, regulatory strategy, and global health authority engagement.
Work setup: travel up to 20%; based in a fast-paced biopharma environment with responsibility for complex, investigational biologics pipelines.