Tonix Pharmaceuticals
Director, Regulatory Affairs - Infectious Disease
Berkeley Heights, NJ · Director
No sponsorship$168k-$246kDetected 8 days ago
Project ManagementRecruitingIntellectual PropertyClinical TrialsFDA RegulatoryLeadershipCommunicationGxPRegulatory Affairs
About the role
- 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 is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction.
Responsibilities
- 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.
- Lead cross‑functional regulatory efforts by partnering with nonclinical, CMC, clinical, project management, and external partners/CROs.
- Proven experience preparing and submitting INDs and related early‑phase regulatory documents.
- Demonstrated ability to independently lead regulatory strategy and cross‑functional teams.
Compensation
- $168,000 - $246,000 USD
- Compensation & Benefits
- Tonix provides a comprehensive compensation and benefits package which includes:
- Retirement Savings 401k with company match and annual discretionary stock options
- 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.
Benefits
- Direct interactions with FDA and other health authorities; prepare teams, lead discussions, and manage responses to queries.
Equal opportunity
- 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.
Visa & Work Authorization
- Please note that Tonix does not offer sponsorship for this role.
Apply directly at Tonix Pharmaceuticals →Create a free account for alerts like thisView Tonix Pharmaceuticals immigration profile
This listing is sourced directly from Tonix Pharmaceuticals's careers page and normalized into a canonical job model.