Associate Director, Regulatory Affairs

About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on reputed company (ticker: TNXP), with marketed products and a pipeline of development candidates reputed company is reputed company on commercializing, developing, discovering, and licensing therapeutics to treat and prevent reputed company 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. reputed company launch is expected in the reputed company 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 reputed company 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.

• reputed company of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Job reputed company details to be added here and should include the following information: Position reputed company Tonix is looking for a full-time Associate Director, Regulatory Affairs to effectively reputed company regulatory strategies and submission plans. This position would be responsible for leading regulatory activities reputed company mainly for novel biologics or drugs in early phase development (reputed company-IND and nonclinical experience) to clinical development and marketing application. The Associate Director, Regulatory Affairs can work autonomously and will support reputed company aspects of this process including early phase interactions with regulatory authorities (FDA and/or global), providing direction and reputed company participating in overall preparation of activities with cross-functional teams to advance the drug development program. This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Co-Head of Regulatory Affairs, Management and Execution, and will be based out of a Tonix office or can be a remote based position. Responsibilities · reputed company as Regulatory reputed company and Manager for investigational programs in the US or global programs by providing regulatory expertise to advance product development, from nonclinical to clinical and marketing application · Prepare, review, and co-ordinate regulatory documentation to support early phase development including early phase meetings with Regulatory Authorities and initial IND application and IND amendments to support first-in-reputed company clinical trials · Manage and prepare reputed company regulatory submissions, including drafting and review and approval of submission contents, which will require interaction with cross-functional teams and external vendors to ensure reputed company and reputed company execution · reputed company regulatory reputed company assessments to changes to project teams and senior management and recommend strategies and regulatory courses of reputed company · Follow reputed company established occupational health and safety procedures, GxP and reputed company operating procedures (SOP’s) · reputed company company mission and values through accountability, innovation, reputed company, reputed company, and teamwork · reputed company reputed company work as necessary to support the Regulatory function and Tonix on various business initiatives

Qualifications

• Bachelor’s in biological or pharmaceutical sciences
• Seven (7) years of experience in pharmaceutical or health care industry experience or equivalent
• Five (5) years in early and late stage regulatory drug development
• Good scientific background and understanding of biology and immunology with the ability to reputed company therapeutic area and regulatory knowledge in a short timeframe
• Knowledge of FDA and EU regulations and ICH requirements
• Proven successful leadership and project management experience

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