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 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…