--- title: 'Associate Director, Regulatory Affairs at Tonix Pharmaceuticals' canonical: 'https://feeny.ai/job/associate-director-regulatory-affairs-tonix-pharmaceuticals-berkeley-heights-nj-h33naazmwxp5' type: 'job' last_seen: '2026-09-09' --- # Associate Director, Regulatory Affairs at Tonix Pharmaceuticals - **Company:** Tonix Pharmaceuticals - **Location:** Berkeley Heights NJ OR Frederick MD OR North Dartmouth MA OR Fort Worth, TX - **Compensation:** $137k–$200k - **Posted:** 2026-04-14 - **Last confirmed live:** 2026-09-09 - **Apply:** https://job-boards.greenhouse.io/tonixpharmaceuticals/jobs/4215536009 ## Job description 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](https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D9p5FBvlzG2u-9NzVEDdUgRNdl57Mw08p4h9XviYYnbwVJ-X_DNEOeN4RdGA64IhTnk9R4lQWNXhq0g8TrvoRTCZSpqmowBapMZCbqP_sxm0%3D&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987080441%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=WrmW8ZuY9XRYJZM0BMPu3thoab5uVHnt9SqBNHIoDuU%3D&reserved=0) and follow the Company on [LinkedIn](https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbldblPUeLBo2VtrimIDsthVk4RaPH1sCjnDw18J2Q9UGKOYpi7kKsd6NuJ4rb7a1ocGevguAt4l_8t8TE5rfCP1YmSBTJO1HR9Uo9KAv_DEwtbEkJhm1CdLRAEbAUNB-&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987109283%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=dHRzyv5dfKFOhCroh809txjNcJOjNrBSQRyfSgHaIu8%3D&reserved=0) and [X](https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D0NgIEJjy96AytWlfgCqgqVv5cOeUVkGOTFS78koSy22XXOczOtXjxSorNUcN-uDTk4CYVQkJndgCk6o2RQBlKQ%3D%3D&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987130654%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=frLcoK5ETOWzJq9lmvkirCS8HaHc2WCX%2Fg4ESMSdLgk%3D&reserved=0). *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 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. ## Key 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 degree 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 - Ability to travel up to 20% - 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 Salary Range $136,500—$200,000 USD *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. ## About Tonix Pharmaceuticals ## Company Overview - **One-liner**: A fully-integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system disorders, immunology, infectious diseases, and rare diseases. - **Entity Type**: Public (NASDAQ: TNXP) - **Headquarters**: Berkeley Heights, New Jersey, United States (as indicated by zip code 07922 on the investor relations page) [ir.tonixpharma.com](https://ir.tonixpharma.com/) - **Founded**: Not publicly available from provided sources - **Founders**: Not publicly available from provided sources ## Core Business - **Primary industry/industries**: Biotechnology / Pharmaceuticals (therapeutics) - **Target customers**: B2B – physicians (rheumatology, primary care, pain management, neurology), hospitals, specialty distributors, and patients through prescription-based access. - **Mission or purpose statement**: “We listen, we develop, we deliver – so that patients feel seen, heard, and empowered to live fully again.” [tonixpharma.com](https://www.tonixpharma.com/) ## Products & Services - **TONMYA® (cyclobenzaprine HCl sublingual tablets)**: Approved in the U.S. (August 2025) and launched in November 2025 for the treatment of fibromyalgia in adults – the first new medicine for fibromyalgia in over 15 years. Non-opioid, centrally acting analgesic designed for bedtime dosing. [tonixpharma.com](https://www.tonixpharma.com/) - **Zembrace® SymTouch® (sumatriptan injection)**: FDA-approved prescription product for the treatment of acute migraine. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **Tosymra® (sumatriptan nasal spray)**: FDA-approved prescription product for acute migraine. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-102 SL (cyclobenzaprine HCl sublingual tablets)**: Investigational for Major Depressive Disorder (Phase 2 planned mid-2026) and Acute Stress Disorder/Reaction (Phase 2 enrolling, OASIS study at UNC funded by DoD). [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-4800 (anti-OspA monoclonal antibody)**: Seasonal prevention of Lyme disease – Phase 2 field study planned first half 2027. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-1500 (humanized anti-CD40L mAb)**: Phase 2-ready for prevention of kidney transplant rejection (investigator-initiated study expected mid-2026) and treatment of autoimmune diseases. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-1300 (double-mutant cocaine esterase)**: Phase 2 for cocaine intoxication; FDA Breakthrough Therapy designation. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-2900 (intranasal oxytocin + magnesium)**: For Prader-Willi Syndrome – Orphan Drug and Rare Pediatric Disease designations; Phase 2 planned Q1 2027. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-801 (horsepox live virus vaccine)**: Preclinical – mpox/smallpox protection; Phase 1 expected in 2027. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-4200 (small molecule anti-CD45)**: Broad-spectrum antiviral for biodefense; preclinical, supported by up to $34M DoD contract. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-1700 (TFF2-albumin fusion)**: Preclinical for gastric/colorectal cancer in combination with PD-1 blockade (in-licensed from Columbia University). [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-4900 (Sigma-1 receptor antagonist)**: Preclinical non-opioid analgesic for neuropathic pain. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) ## Market Standing - **Valuation/Market Cap**: Not publicly available from provided sources (public stock; market cap fluctuates) - **Key Metric**: Annual Revenue – Not disclosed in provided sources (commercial launch of TONMYA began November 2025; earlier revenue from Zembrace/Tosymra). Total funding rounds not applicable for public company. R&D expenditures detailed in 10-K but not extracted. - **Notable Investors/Partners**: Almac Pharma Services (commercial supply for TONMYA) [10-K]; U.S. Department of Defense (DTRA contract up to $34M for TNX-4200) [10-K]; University of North Carolina (OASIS study for TNX-102 SL) [10-K]; Columbia University (TNX-1700 in-license) [10-K]. - **Growth Signals**: First FDA approval and launch of internally developed drug TONMYA (Nov 2025); expanding commercial payer coverage (second commercial agreement covering ~52M U.S. lives) [tonixpharma.com]; multiple Phase 2 programs advancing; ownership of two manufacturing facilities (RDC in Frederick, MD and ADC in Dartmouth, MA) [10-K]. ## Competitive Advantages - **First-mover in fibromyalgia**: TONMYA is the first new FDA-approved treatment for fibromyalgia in 15+ years, with a proprietary sublingual formulation that offers differentiated bioavailability and tolerability. - **Broad, diversified pipeline**: Covers CNS, immunology, infectious disease, and rare disease – reducing single-program risk and providing multiple shots on goal. - **In-house manufacturing**: Owned R&D Center (Frederick, MD) with BSL-2/3 capability and an Advanced Development Center (Dartmouth, MA) for live-virus vaccine and biologics production (currently decommissioned but ready for reactivation) [10-K]. - **Non-opioid focus**: All analgesic candidates (TONMYA, TNX-4900) are non-opioid, aligning with regulatory and societal trends away from opioids. - **Government partnerships**: DTRA contract for biodefense work (TNX-4200) provides non-dilutive funding and mission relevance. ## Strategic Focus - **Grow TONMYA**: Expand commercial coverage, physician adoption, and patient access for fibromyalgia treatment. - **Advance pipeline**: Initiate or complete Phase 2 studies for TNX-102 SL (MDD, ASD), TNX-4800 (Lyme), TNX-1500 (transplant rejection), TNX-1300 (cocaine intoxication), TNX-2900 (Prader-Willi), and move TNX-801 (mpox/smallpox vaccine) into Phase 1. - **Pursue strategic business development**: In-licensing, partnerships, and potential acquisitions to augment pipeline and commercial portfolio [10-K]. ## Why Work Here - **Culture**: The company emphasizes a collaborative, inclusive environment where every voice is heard. Mission-driven focus on “listening to patients’ lived experiences” and developing therapies for underserved, complex conditions. [tonixpharma.com/careers](https://www.tonixpharma.com/careers/) - **Work model**: Information on remote/hybrid policy not publicly available. Office and lab facilities in Berkeley Heights, NJ (HQ), Frederick, MD (R&D Center), and Dartmouth, MA (Advanced Development Center). - **Team & growth**: Opportunity to work on first-in-class drug launches (TONMYA) and cutting-edge science across multiple therapeutic areas. The company is at a pivotal stage transitioning from pure R&D to a commercial organization, offering varied career pathways. - **Benefits**: Equal opportunity employer; does not offer visa sponsorship for open positions. [tonixpharma.com/careers](https://www.tonixpharma.com/careers/) - **Notable perks/engineering culture**: Not detailed, but the science-driven environment with in-house manufacturing and government-funded biodefense work may appeal to researchers and engineers in pharma. ## Sources 1. [tonixpharma.com](https://www.tonixpharma.com/) – Company homepage, mission, product info, lat _…truncated._ ## Other roles at Tonix Pharmaceuticals - [Executive Assistant to the Chief Executive Officer](https://feeny.ai/job/executive-assistant-to-the-chief-executive-officer-tonix-pharmaceuticals-q21ne61fzfhr) — Berkeley Heights NJ OR New York, NY - [Regional Sales Director - California](https://feeny.ai/job/regional-sales-director-california-tonix-pharmaceuticals-california-8thn8v1c8d4r) — California - [Associate Medical Director, Clinical Development](https://feeny.ai/job/associate-medical-director-clinical-development-tonix-pharmaceuticals-berkeley-pa6mx85qwvws) — Berkeley Heights, NJ - [Manager, Financial Reporting](https://feeny.ai/job/manager-financial-reporting-tonix-pharmaceuticals-berkeley-heights-x4szc7r8yxkq) — Berkeley Heights, NJ - [Senior Associate, Supplier Quality](https://feeny.ai/job/senior-associate-supplier-quality-tonix-pharmaceuticals-north-dartmouth-ma-or-bfw25b7mxm0z) — North Dartmouth MA OR Berkeley Height, NJ - [Scientist II, In-Vitro & Nonclinical Assay Development](https://feeny.ai/job/scientist-ii-in-vitro-nonclinical-assay-development-tonix-pharmaceuticals-xfw3p1cqhsr3) — Frederick, MD - [Senior Manager, Information Security](https://feeny.ai/job/senior-manager-information-security-tonix-pharmaceuticals-frederick-md-or-062sk1rtyd2t) — Frederick MD OR Berkeley Heights, NJ - [​Pharmaceutical Management Rotational Program Associate​](https://feeny.ai/job/pharmaceutical-management-rotational-program-associate-tonix-pharmaceuticals-y27n7mcn4xq0) — Berkeley Heights, NJ - [Senior Specialist, Corporate Communications](https://feeny.ai/job/senior-specialist-corporate-communications-tonix-pharmaceuticals-berkeley-0rn9ax1k9r08) — Berkeley Heights NJ OR New York, NY - [Associate Director, Commercial Analytics & Sales Force Effectiveness](https://feeny.ai/job/associate-director-commercial-analytics-sales-force-effectiveness-tonix-21gmwfrwft16) — Berkeley Heights, NJ