Director, Regulatory Affairs - Infectious Disease
Tonix Pharmaceuticals Holding Corp.About Tonix*
Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.
Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA.
Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
Please visit www.Tonixpharma.com for specifics on the pipeline.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
Position Overview
The Director, Regulatory Affairs for Infectious Diseases will serve as the primary Regulatory Lead for Tonix’s infectious disease biologics programs. This role oversees global regulatory strategy, submissions, health authority interactions, and cross‑functional leadership from early development (nonclinical, pre‑IND) through clinical stages. The ideal candidate is proactive, strategic, and comfortable operating with minimal oversight while driving timelines and influencing team direction. This position will report directly to the Head of Regulatory Affairs and will be based at a Tonix office or can be a remote-based position.
Essential Duties
- Serve as Regulatory Lead for biologics, focused on infectious diseases programs.
- Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.
- Lead preparation, authorship, and coordination of regulatory submissions, including pre‑IND packages, INDs, amendments, and briefing documents.
- Direct interactions with FDA and other health authorities; prepare teams, lead discussions, and manage responses to queries.
- Lead cross‑functional regulatory efforts by partnering with nonclinical, CMC, clinical, project management, and external partners/CROs.
- Assess regulatory risks, impacts, and mitigation options; communicate recommendations to internal teams and senior leadership.
- Ensure compliance with FDA, ICH, and global regulatory requirements, as well as internal SOPs and GxP standards.
- Oversee regulatory documentation quality and timely delivery of program milestones.
Necessary Skills and Abilities
- Strong scientific foundation in immunology, infectious diseases, or related biological disciplines.
- Proven experience preparing and submitting INDs and related early‑phase regulatory documents.
- Demonstrated ability to independently lead regulatory strategy and cross‑functional teams.
- Strong knowledge of FDA, ICH, EU, and applicable global regulatory guidelines.
- Excellent written and verbal communication skills, including regulatory writing and team communication.
- Strong organizational, planning, and prioritization skills with high attention to detail.
- Ability to manage multiple responsibilities in a fast‑paced, dynamic environment.
- Ability to work independently with minimal oversight while collaborating effectively across functions.
- Ability to travel up to 20%.
Educational Requirements
- Bachelor’s degree in biological sciences, pharmaceutical sciences, or related field; advanced degree preferred.
Experience Requirements
- 10–12+ years of progressively responsible regulatory experience with demonstrated program leadership.
*Please note that Tonix does not offer sponsorship for this role.
Recruitment & Staffing Agencies
Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.
Compensation & Benefits
Tonix provides a comprehensive compensation and benefits package which includes:
- Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
- Pet Insurance
- Retirement Savings 401k with company match and annual discretionary stock options
- Generous Paid Time Off, Sick Time, & Paid Holidays
- Career Development and Training
Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. Â In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. Â This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Â Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
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