Tonix Pharmaceuticals · 5 days ago
Senior Specialist, Regulatory Operations
Berkeley Heights, NJ
Full-time
Hybrid
Mid, Senior Level
$70K/yr - $130K/yr
3+ years expTonix Pharmaceuticals is a fully integrated biotechnology company focused on commercializing and developing therapeutics to treat and prevent human diseases. The Senior Specialist, Regulatory Operations, will manage submission processes and collaborate with various teams to ensure timely and compliant regulatory submissions for the company's product pipeline.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables
This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities
Serve as submission manager and primary contact for publishing vendors and internal stakeholders
Oversee regulatory document management, tracking, and archival activities
Manage regulatory systems (e.g., Veeva RIM, PromoMats), and serve as internal subject matter expert (SME) for training and support to internal stakeholders
Develop and implement processes, templates, and tools that improve submission efficiency and consistency
Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases
Provide subject matter expertise on regulatory technologies and submission best practices
Monitor new regulations and industry trends to assess impact on operational practices
Any other supporting activities or research, as needed, for the regulatory team
Qualification
Required
Bachelor's degree in a scientific or related field
3-4 years of regulatory operations experience in biotech or pharmaceutical industry
Strong understanding of eCTD submission standards and regulatory requirements across global regions
Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management
Hands-on experience with Veeva RIM and/or PromoMats strongly preferred
Experience managing outsourced publishing vendors a plus
Skilled at balancing strategic oversight with hands-on execution
Strong communicator and collaborator with excellent organizational skills
Ability to travel 10% of the time
Preferred
Hands-on experience with Veeva RIM and/or PromoMats strongly preferred
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
Company
Tonix Pharmaceuticals
Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$336.74MKey Investors
Point72Medical CBRN Defense ConsortiumTechnology Partners
2025-12-29Post Ipo Equity· $20M
2025-03-10Grant
2024-06-12Post Ipo Equity· $4M
Leadership Team
Seth Lederman
CEO
Zeil Rosenberg
Executive Vice President, Medical
Recent News
2025-12-29
2025-12-29
Company data provided by crunchbase