Associate Director, Regulatory Affairs

About the role

Tonix Pharmaceuticals is a fully integrated, commercial-stage biotechnology company focused on CNS and immunology treatments. Its marketed products include TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) for fibromyalgia, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg) for acute migraine. The company is advancing TONMYA® in Phase 2 trials for major depressive disorder and acute stress disorder/acute stress reaction, and a pipeline of immunology programs including TNX-4800 (Phase 2 ready long-acting anti-Borrelia OspA mAb for Lyme disease prevention), TNX-1500 (Phase 2 ready third‑generation CD40 ligand inhibitor for kidney transplant rejection prevention), and TNX-2900 (intranasal potentiated oxytocin, Phase 2 ready for Prader‑Willi syndrome). The Associate Director, Regulatory Affairs will develop regulatory strategies and submission plans for novel biologics or drugs in early‑phase development (pre‑IND and nonclinical) through clinical development and marketing application, working autonomously, leading regulatory activities, supporting early‑phase interactions with FDA/global authorities, and participating in cross‑functional preparation of activities to advance drug development programs. The role reports to the Co‑Head of Regulatory Affairs, Management and Execution and can be based in a Tonix office or remote.

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

Pay

Salary Range: $136,500 USD - $200,000 USD

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