Associate Director Regulatory Affairs
Tonix Pharmaceuticals
August 12, 2026
Remote friendly (Berkeley Heights, NJ)
United States
Corporate Functions
Position Overview
- Full-time Associate Director, Regulatory Affairs responsible for developing regulatory strategies and submission plans for novel biologics in early phase development (pre-IND to clinical development and marketing applications). Works autonomously; leads early phase interactions with regulators (FDA and/or global) and collaborates cross-functionally.
Responsibilities
- Serve as US Regulatory Lead for infectious disease and immunological/autoimmune biologics; advance development from nonclinical through clinical and marketing application.
- Prepare/review/coordinate regulatory documentation for early phase development, including early phase meetings and initial IND/IND amendments for first-in-human trials.
- Manage and prepare complex regulatory submissions (drafting, review, approval), coordinating with cross-functional teams and external vendors.
- Provide regulatory impact assessments for project changes and recommend regulatory strategies.
- Follow occupational health/safety procedures, GxP, and SOPs.
- Perform ad-hoc regulatory work to support business initiatives.
Minimum Qualifications
- Bachelor’s in biological-related subjects or pharmaceutical sciences.
- 5 years in biologics regulatory drug development (early and late stage).
- Strong knowledge of biology/immunology; ability to quickly gain therapeutic area/regulatory knowledge.
- Knowledge of FDA/EU regulations and ICH requirements.
- Proven leadership and project management.
- Direct experience writing IND/clinical trial/marketing application submission documents.
- Experience developing and implementing regulatory strategies.
- Strong planning/organizational skills; excellent written/verbal communication.
- Ability to work independently and collaboratively; drive timelines with internal/external parties.
- Travel ~20%.
Benefits
- Annual base salary range: $130,000–$200,000 plus target incentive.
- Medical/dental/vision, life/AD&D, short-/long-term disability, FSA, HSA, EAP; pet insurance; 401(k) match and stock options; paid time off, sick time, paid holidays; career development/training.
Application Instructions
- Tonix does not accept agency resumes unless contacted by internal Talent Acquisition; do not forward resumes to employees or other locations.
- Full-time Associate Director, Regulatory Affairs responsible for developing regulatory strategies and submission plans for novel biologics in early phase development (pre-IND to clinical development and marketing applications). Works autonomously; leads early phase interactions with regulators (FDA and/or global) and collaborates cross-functionally.
Responsibilities
- Serve as US Regulatory Lead for infectious disease and immunological/autoimmune biologics; advance development from nonclinical through clinical and marketing application.
- Prepare/review/coordinate regulatory documentation for early phase development, including early phase meetings and initial IND/IND amendments for first-in-human trials.
- Manage and prepare complex regulatory submissions (drafting, review, approval), coordinating with cross-functional teams and external vendors.
- Provide regulatory impact assessments for project changes and recommend regulatory strategies.
- Follow occupational health/safety procedures, GxP, and SOPs.
- Perform ad-hoc regulatory work to support business initiatives.
Minimum Qualifications
- Bachelor’s in biological-related subjects or pharmaceutical sciences.
- 5 years in biologics regulatory drug development (early and late stage).
- Strong knowledge of biology/immunology; ability to quickly gain therapeutic area/regulatory knowledge.
- Knowledge of FDA/EU regulations and ICH requirements.
- Proven leadership and project management.
- Direct experience writing IND/clinical trial/marketing application submission documents.
- Experience developing and implementing regulatory strategies.
- Strong planning/organizational skills; excellent written/verbal communication.
- Ability to work independently and collaboratively; drive timelines with internal/external parties.
- Travel ~20%.
Benefits
- Annual base salary range: $130,000–$200,000 plus target incentive.
- Medical/dental/vision, life/AD&D, short-/long-term disability, FSA, HSA, EAP; pet insurance; 401(k) match and stock options; paid time off, sick time, paid holidays; career development/training.
Application Instructions
- Tonix does not accept agency resumes unless contacted by internal Talent Acquisition; do not forward resumes to employees or other locations.