CMC Regulatory Affairs Associate

Job Title: CMC Regulatory Affairs AssociateLocation: North Chicago, IL (Hybrid)Experience: 1 2 yearsContract Duration: 12+ Months (possible extension)Requirement: LinkedIn profile requiredRole Overview 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.Key ResponsibilitiesAuthor, compile, and maintain Module 3 (CMC) sections for CTD and eCTD submissionsSupport regulatory filings including INDs, NDAs, ANDAs, BLAs, and post‑approval changesEnsure CMC documentation aligns with ICH guidelines, with emphasis on ICH M4QCollaborate with CMC, analytical, process development, and quality teamsReview technical and scientific data and convert it into regulatory‑ready contentSupport global regulatory submissions and health authority interactions as neededMaintain accurate and compliant regulatory documentation and recordsAssist in preparing responses to regulatory agency questions related to CMCMust-Have Qualifications (Deal Breakers)1 2 years of experience in the pharmaceutical industryStrong hands‑on experience in CMC regulatory activitiesDirect experience authoring Module 3 contentWorking knowledge of CTD and eCTD submission formatsSolid understanding of ICH guidelines, specifically ICH M4QBachelor's or Master's degree in Chemical Sciences, Biological Sciences, or a related fieldStrong written and verbal communication skillsNice-to-Have QualificationsBackground in analytical chemistry or process chemistryExperience supporting global regulatory submissionsExposure to Technical File documentationMedical device experience only if combined with pharmaceutical CMC experienceNot a Fit ForLabeling-focused regulatory rolesPublishing-only profiles without CMC authoring experienceOperations or coordination-only regulatory positions#J-18808-Ljbffr