Senior Director, Regulatory Affairs – Infectious Disease

Scorpion Therapeutics; Berkeley Heights (NJ); On-site; USD 170,000 - 230,000; Full time

Job summary

Tonix Pharmaceuticals seeks a Senior Director, Regulatory Affairs for Infectious Disease to lead global regulatory activities for biologics and vaccines from development through registration.

You will develop and execute regulatory strategies across nonclinical, CMC, clinical, and post-marketing phases, manage submissions, and interact with FDA and global authorities while guiding lifecycle management and ensuring compliance with international standards.

Qualifications

• 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.
• Experience with INDs, CTAs, agency interactions, and global regulations (FDA, ICH, EU).
• Preferred: advanced degree, mentoring regulatory teams.

Responsibilities

• Develop and execute regulatory strategies across nonclinical, CMC, clinical, and post-marketing phases.
• Lead preparation of submissions and interactions with FDA and global authorities.
• Guide lifecycle management and compliance with global regulations.
• Collaborate with cross-functional teams and external partners.

Skills

Regulatory strategy

Global leadership

IND/CTA experience

FDA interactions

ICH/EU knowledge

Vaccine/Biologics

Cross-functional collaboration

Education

Bachelor's in biological/pharmaceutical sciences

Advanced degree preferred

Job description

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.
HighValue: 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.