CMC Regulatory Affairs Associate

Job Title: CMC Regulatory Affairs Associate

Location: North Chicago, IL (Hybrid)

Experience: 1 2 years

Contract Duration: 12+ Months (possible extension)

Requirement: Linked In profile required

The CMC Regulatory Affairs Associate will support regulatory submission activities with a strong focus on Chemistry, Manufacturing, and Controls. This role is hands‑on and centered on authoring, reviewing, and managing Module 3 content for CTD and eCTD submissions within a pharmaceutical environment.

• Author, compile, and maintain Module 3 (CMC) sections for CTD and eCTD submissions
• Support regulatory filings including INDs, NDAs, ANDAs, BLAs, and post‑approval changes
• Ensure CMC documentation aligns with ICH guidelines, with emphasis on ICH M4Q
• Collaborate with CMC, analytical, process development, and quality teams
• Review technical and scientific data and convert it into regulatory‑ready content
• Support global regulatory submissions and health authority interactions as needed
• Maintain accurate and compliant regulatory documentation and records
• Assist in preparing responses to regulatory agency questions related to CMC

• 1 2 years of experience in the pharmaceutical industry
• Strong hands‑on experience in CMC regulatory activities
• Direct experience authoring Module 3 content
• Working knowledge of CTD and eCTD submission formats
• Solid understanding of ICH guidelines, specifically ICH M4Q
• Bachelor's or Master's degree in Chemical Sciences, Biological Sciences, or a related field
• Strong written and verbal communication skills

• Background in analytical chemistry or process chemistry
• Experience supporting global regulatory submissions
• Exposure to Technical File documentation
• Medical device experience only if combined with pharmaceutical CMC experience

• Labeling-focused regulatory roles
• Publishing-only profiles without CMC authoring experience
• Operations or coordination-only regulatory positions