Tonix Pharmaceuticals

• Establish, broaden, and deepen relationships with target entities (e.g., health insurers, PBM’s, other payers, etc.) and key decision makers and influencers (pharmacy and medical directors, etc.) that affect coverage and reimbursement decisions. • Positively influence decision makers, policies, guidelines and contracts to facilitate timely and appropriate coverage, access and reimbursement for our drug candidates and approved products. • Develop account specific plans and assist in the resolution of access/reimbursement issues. • Work closely with the MSL team to support the communication and understanding of our drug candidates and approved products with payers. • Work closely with the Patient Services team to support the patient journey and resolve coverage issues. • Assist Regional Sales teams with pull- or sell-through strategies based on payer coverage. • Represent Tonix at industry events, including Asembia, AMCP, and other relevant conferences. • Uphold the highest standards of professionalism, compliance, and ethical conduct in all internal and external interactions.

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 - 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 Salary Range $190,000—$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.

• Provide quality oversight and support across all GCP, GLP, IND Enabling, and bioanalytical studies and programs. • Partner strategically with Clinical Operations and Nonclinical functions. • Oversee audit professionals/consultants for quality oversight of regulated study activities. • Explain quality standards to other functions as an SME and advisor. • Support internal and contracted organization activities. • Lead, direct, and advise continuous improvement of the department’s area of control.

• Define and lead the company’s clinical development strategy for assigned vaccines and prophylactic antibodies • Oversee the planning, design, execution, and completion of clinical trials • Oversee the development of clinical protocols, investigator brochures, statistical analysis plans, and other critical regulatory documents • Collaborate with clinical operations to ensure the quality and integrity of clinical data • Maintain a strong focus on innovation in clinical trial design • Oversee the selection and management of CROs, academic partnerships, and external collaborations • Drive a culture of operational excellence, regulatory compliance, quality assurance, and ethical considerations across Clinical Development • Represent the company at key scientific conferences and industry consortia • Provide leadership to the Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams • Serve as the clinical development leader for assigned pipeline programs in interactions with global regulatory agencies • Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations • Build, mentor, and lead high-performing teams

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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. Qualifications - 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 to travel up to 20%. Educational Requirements - Bachelor’s degree in biological sciences, pharmaceutical sciences, or related field; advanced degree preferred. Experience Requirements - 10–12+ years of progressively responsible regulatory experience with demonstrated program leadership. Salary Range $130,000 — $200,000 USD Compensation & Benefits - Medical, Dental & Vision Insurance - Basic and Voluntary Life and AD&D Insurance - Short- and Long-Term Disability Insurance - Flexible Spending Accounts - Health Savings Account - 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