Associate Director, Regulatory Affairs
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.
Job description details to be added here and should include the following information: Position Overview Tonix is looking for a full-time Associate Director, Regulatory Affairs to effectively develop regulatory strategies and submission plans. This position would be responsible for leading regulatory activities related mainly for novel biologics or drugs in early phase development (pre-IND and nonclinical experience) to clinical development and marketing application. The Associate Director, Regulatory Affairs can work autonomously and will support all aspects of this process including early phase interactions with regulatory authorities (FDA and/or global), providing direction and actively 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 · Act as Regulatory Lead 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-human clinical trials · Manage and prepare complex regulatory submissions, including drafting and review and approval of submission contents, which will require interaction with cross-functional teams and external vendors to ensure timely and quality execution · Provide regulatory impact assessments to changes to project teams and senior management and recommend strategies and regulatory courses of action · Follow all established occupational health and safety procedures, GxP and standard operating procedures (SOP’s) · Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork · Perform ad-hoc 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 acquire 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