Director of Regulatory Affairs - Infectious Disease
Tonix Pharmaceuticals
August 12, 2026
Remote friendly (Berkeley Heights, NJ)
United States
Corporate Functions
Position Overview
- Director, Regulatory Affairs for Infectious Diseases. Primary Regulatory Lead for Tonix’s infectious disease biologics programs; global regulatory strategy and submissions from nonclinical/pre-IND through clinical stages. Reports to Head of Regulatory Affairs; based in-office or remote.
Responsibilities
- Serve as Regulatory Lead for infectious disease biologics.
- Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.
- Lead preparation/authorship/coordination of regulatory submissions (pre-IND packages, INDs, amendments, briefing documents).
- Direct FDA and other health authority interactions; prepare teams, lead discussions, manage responses to queries.
- Lead cross-functional regulatory efforts with nonclinical, CMC, clinical, project management, and external partners/CROs.
- Assess regulatory risks/impacts; communicate mitigation recommendations to internal teams and senior leadership.
- Ensure compliance with FDA, ICH, global regulatory requirements, internal SOPs, and GxP.
- Oversee regulatory documentation quality and timely program milestone delivery.
Qualifications (Education/Experience)
- Bachelor’s degree in biological or pharmaceutical sciences or related field; advanced degree preferred.
- 10–12+ years of progressively responsible regulatory experience with demonstrated program leadership.
Skills
- Scientific foundation in immunology/infectious diseases.
- Experience preparing and submitting INDs and early-phase regulatory documents.
- Knowledge of FDA, ICH, EU, and global regulatory guidelines.
- Strong regulatory writing and written/verbal communication.
- Organizational/planning/prioritization; high attention to detail.
- Ability to lead independently with minimal oversight; collaborate cross-functionally.
- Travel up to 20%.
Benefits
- Medical, Dental & Vision; Life/AD&D; Short- and Long-Term Disability; Flexible Spending; HSA; Employee Assistance Programs; Pet Insurance; 401(k) with company match and annual discretionary stock options; Paid Time Off, Sick Time, and Paid Holidays; Career Development and Training.
- Director, Regulatory Affairs for Infectious Diseases. Primary Regulatory Lead for Tonix’s infectious disease biologics programs; global regulatory strategy and submissions from nonclinical/pre-IND through clinical stages. Reports to Head of Regulatory Affairs; based in-office or remote.
Responsibilities
- Serve as Regulatory Lead for infectious disease biologics.
- Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.
- Lead preparation/authorship/coordination of regulatory submissions (pre-IND packages, INDs, amendments, briefing documents).
- Direct FDA and other health authority interactions; prepare teams, lead discussions, manage responses to queries.
- Lead cross-functional regulatory efforts with nonclinical, CMC, clinical, project management, and external partners/CROs.
- Assess regulatory risks/impacts; communicate mitigation recommendations to internal teams and senior leadership.
- Ensure compliance with FDA, ICH, global regulatory requirements, internal SOPs, and GxP.
- Oversee regulatory documentation quality and timely program milestone delivery.
Qualifications (Education/Experience)
- Bachelor’s degree in biological or pharmaceutical sciences or related field; advanced degree preferred.
- 10–12+ years of progressively responsible regulatory experience with demonstrated program leadership.
Skills
- Scientific foundation in immunology/infectious diseases.
- Experience preparing and submitting INDs and early-phase regulatory documents.
- Knowledge of FDA, ICH, EU, and global regulatory guidelines.
- Strong regulatory writing and written/verbal communication.
- Organizational/planning/prioritization; high attention to detail.
- Ability to lead independently with minimal oversight; collaborate cross-functionally.
- Travel up to 20%.
Benefits
- Medical, Dental & Vision; Life/AD&D; Short- and Long-Term Disability; Flexible Spending; HSA; Employee Assistance Programs; Pet Insurance; 401(k) with company match and annual discretionary stock options; Paid Time Off, Sick Time, and Paid Holidays; Career Development and Training.