​​Senior Director, Regulatory Affairs – Infectious Disease​

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Position Overview
The Senior Director, Regulatory Affairs for Infectious Disease will serve as the senior Regulatory Lead for Tonix’s assigned infectious disease biologics and vaccine programs, providing strategic leadership from early development through initial product registration. The role will shape global development and regulatory plans, lead health authority strategy and interactions, and integrate regulatory input across clinical, nonclinical, and CMC disciplines. The ideal candidate is a strategic, proactive leader who can independently navigate complex regulatory issues, anticipate regulatory and business needs, influence development strategy, and provide clear recommendations to cross-functional teams and senior leadership.
Key Responsibilities
Serve as the senior Regulatory Lead for biologics, focused on infectious disease programs, providing strategic regulatory leadership across assigned programs.
Develop, lead, and execute global regulatory strategies across nonclinical, CMC, clinical development, registration, commercialization, and lifecycle management.
Lead preparation, authorship, and coordination of regulatory submissions across the product lifecycle, including pre-IND packages, INDs, amendments, briefing documents, marketing applications, supplements, and post-approval submissions.
Serve as a senior regulatory representative in interactions with FDA and other global health authorities; lead regulatory meetings, negotiations, and responses to complex regulatory issues.
Provide regulatory leadership for commercial and post-approval activities, including product labeling, promotional considerations, lifecycle management, and implementation of post-marketing commitments and requirements.
Lead cross-functional regulatory efforts by partnering with nonclinical, CMC, clinical, commercial, medical affairs, project management, and external partners/CROs.
Anticipate and assess regulatory risks, impacts, and mitigation strategies; provide strategic recommendations to cross-functional teams and senior leadership.
Ensure compliance with FDA, ICH, and global regulatory requirements, as well as internal SOPs and GxP standards.