Senior Director, Infectious Disease Regulatory Strategy

Tonix Pharmaceuticals; Berkeley Heights, Frederick (NJ, MD); On-site; USD 200,000 - 275,000; Full time

Benefits offered by this job

Health insurance

Pet insurance

401k with company match

Paid time off

Career development

Job summary

Tonix Pharmaceuticals is seeking a Senior Director, Regulatory Affairs for Infectious Disease to lead global regulatory strategy from early development through product registration. This senior role requires strategic thinking, strong FDA experience, and the ability to drive cross‑functional teams across CMC, nonclinical, and clinical development.

Based in Berkeley Heights, NJ, the role involves interactions with health authorities worldwide, authorship of submissions, and oversight of

Qualifications

• Bachelor’s degree in biological sciences or related field; an advanced scientific degree is strongly preferred.
• Minimum of 12 years of progressively responsible regulatory affairs experience, including substantial global regulatory strategy work for vaccine or infectious disease programs.
• Proven experience leading regulatory submissions, FDA interactions, and cross-functional governance for complex development programs.

Responsibilities

• Lead global regulatory strategies across nonclinical, CMC, clinical development, and lifecycle management.
• Oversee preparation and coordination of regulatory submissions (INDs, amendments, briefing documents, BLA/MAAs).
• Serve as senior regulatory representative in interactions with FDA and other health authorities; lead agency meetings and responses.

Skills

Regulatory affairs

Vaccine regulation

Infectious disease

FDA interactions

Global regulatory strategy

Regulatory writing

Cross-functional leadership

Executive communication

Team mentoring

Education

Bachelor’s degree in biological sciences

Advanced scientific degree preferred

Job description

Tonix Pharmaceuticals is seeking a Senior Director, Regulatory Affairs for Infectious Disease to lead global regulatory strategy from early development through product registration. This senior role requires strategic thinking, strong FDA experience, and the ability to drive cross‑functional teams across CMC, nonclinical, and clinical development.

Based in Berkeley Heights, NJ, the role involves interactions with health authorities worldwide, authorship of submissions, and oversight of