Associate Director Regulatory Affairs

About Tonix

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.

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.

About the Role

Tonix is looking for a full-time Associate Director, Regulatory Affairs to effectively develop regulatory strategies and submission plans. This position will lead regulatory activities related mainly to novel biologics (large molecule/infectious disease, autoimmune disease programs) in early phase development (pre-IND and nonclinical experience) through clinical development and marketing application. The role supports early phase interactions with regulatory authorities (FDA and/or global) and actively participates 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. The position reports directly to the Director of Regulatory Affairs and may be based out of a Tonix office or remote.

Responsibilities

• Act as Regulatory Lead for biologics programs in the US for infectious disease, immunological/autoimmune indications by providing regulatory expertise to advance product development, from nonclinical to clinical and marketing application.
• Prepare, review, and coordinate 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 (SOPs).
• 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.

Requirements

• Bachelor’s degree in biological-related subjects or pharmaceutical sciences.
• Five (5) years of experience in biologics, 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.
• 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.

Pay

Annualized base salary ranges from $130,000 to $200,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit.

Benefits

• Medical, Dental & Vision Insurance.
• Basic and Voluntary Life and AD&D Insurance.
• Short- and Long-Term Disability Insurance.
• Flexible Spending Accounts and 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.