Senior Regulatory Director, Infectious Disease Biologics

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision Insurance

401(k) with match

Stock options

Job summary

Tonix Pharmaceuticals seeks a Senior Director of Regulatory Affairs for Infectious Disease to drive global regulatory strategy across biologics and vaccines from early development through initial product registration.

You will lead health authority interactions, coordinate cross-functional teams, and shape development plans while navigating complex regulatory pathways in a fast-paced biopharma environment.

Qualifications

• Bachelor’s degree in biological sciences or related field; advanced scientific degree preferred.
• 12+ years of regulatory affairs experience, including global strategy for vaccine or infectious disease programs.
• Experience leading regulatory submissions and agency interactions (FDA and others).

Responsibilities

• Serve as senior Regulatory Lead for infectious disease biologics programs.
• Develop and execute global regulatory strategies across nonclinical, CMC, clinical, registration, and lifecycle management.
• Lead preparation and coordination of regulatory submissions (INDs, amendments, BRDs, PMAs/BLAs).
• Lead FDA interactions, meetings, negotiations, and agency responses.

Skills

Regulatory leadership

Global regulatory strategy

Regulatory submissions

FDA interactions

Cross-functional leadership

Education

Bachelor’s degree in biological sciences

Advanced degree preferred

Job description

Tonix Pharmaceuticals seeks a Senior Director of Regulatory Affairs for Infectious Disease to drive global regulatory strategy across biologics and vaccines from early development through initial product registration.

You will lead health authority interactions, coordinate cross-functional teams, and shape development plans while navigating complex regulatory pathways in a fast-paced biopharma environment.