Sr Associate, Regulatory Affairs, CMC

Tonix Pharmaceutical • North Dartmouth, MA

52d • $70,000 - $120,000

About The Position

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.

Requirements

• 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).
• 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.

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.

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, 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 51-100 employees