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

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
• Experience directly writing submission documents that support IND applications, clinical trials, and marketing applications
• Experience developing and implementing regulatory strategies

Skills and Abilities

• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Strong planning and organizational skills and attention to detail with accuracy and quality
• Excellent written and verbal communication skills
• Able to work independently with minimal supervision and collaboratively with team members
• Able to effectively interact with internal and external parties to drive projects through to completion to tight timelines
• Ability for travel 20% of the time

*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.  In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment.  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.  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.