Job Description

Job Title: CMC Regulatory Affairs Associate
Location: North Chicago, IL (Hybrid)
Experience: 1 2 years
Contract Duration: 12+ Months (possible extension)
Requirement: LinkedIn 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

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