Sr Associate, Regulatory Affairs, CMC

Job Description

Job Description

About Tonix*

Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. 

Position Overview

The Regulatory Affairs Specialist – CMC is responsible for supporting global regulatory submissions and lifecycle management activities related to the chemistry, manufacturing, and controls (CMC) components of drug development. This role ensures that all CMC documentation complies with applicable regulatory requirements and company standards, enabling timely approvals and continued product compliance.

Essential Duties and Responsibilities

• Prepares and/or coordinate activities for investigation and new product registrations, post approval changes, renewals, annual reports, and extension applications ensuring on-time and high-quality global submissions.
• Interface with external Contract Manufacturing Organizations (CMO) and relevant functional teams in obtaining the necessary CMC documentation in support of a regulatory submission.
• Execute preparation of timely responses to CMC regulatory questions in coordination with Subject Matter Experts (SME) as needed.
• Reviews and assesses change control requests pertaining to CMC aspects and coordinates filing strategies with minimal assistance; attend change control meetings as regulatory-CMC representative.
• Maintain submission information according to the document management system, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
• Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements.
• Participate in ad-hoc or special regulatory projects as needed.

Necessary Skills and Abilities

• Familiarity with global CMC regulations, including ICH requirements and US/EU regulatory guidances.
• Experience in authoring technical documents, CTD M2 and M3 sections.
• Experience with post-approval CMC changes and lifecycle management.
• Strong oral and written communication skills with superior attention to detail.
• Demonstrates initiative and is proactive; ability to work independently and within a team setting.
• Proficiency in Microsoft Office programs and other regulatory databases (e.g. Track wise, Veeva, eCTD publishing software).

Educational and Experience Requirements

• Minimum of a bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Chemistry).
• 4 + years of experience in Regulatory Affairs specifically with Small Molecules focused on Regulatory CMC.
• Good understanding of the drug development and life-cycle management process.

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

Annualized base salary ranges from $70,000 to $120,000 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.

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.