Regulatory Affairs Associate II

Job Title: Regulatory Affairs CMC Project Manager Location: Lake County, IL (Hybrid) Pay Rate: $33–$35/hour Duration: 6 Months (Initial Contract) Job Description Manage the authoring, compilation, and coordination of Chemistry, Manufacturing, and Controls (CMC) sections for marketed product variation submissions. Develop CTD Module 3 content and project timelines in collaboration with Regulatory Affairs CMC leads and cross-functional teams. Ensure regulatory dossiers and responses meet accuracy, completeness, formatting, and submission requirements. Lead document review meetings, track project milestones, and coordinate regulatory documentation activities to support timely filings and acceptance. Education Bachelor’s degree in Chemistry, Biological Sciences, or a related scientific discipline. Required Skills At least 4 years of pharmaceutical industry experience. Experience authoring, compiling, or managing CMC regulatory submission documents. Knowledge of CTD structure, particularly Module 3 requirements. Experience coordinating cross-functional regulatory projects and submission timelines. Familiarity with U.S. and international regulatory dossier requirements. Experience using electronic document management systems. Ability to manage multiple regulatory projects independently. Preferred Skills At least 5 years of pharmaceutical industry experience, including 1–2 years in Regulatory Affairs, R&D, or Manufacturing. Experience preparing CMC sections for marketed product variations. Knowledge of regulatory submission best practices and electronic regulatory business systems. Experience reviewing technical documentation and coordinating responses to regulatory questions. #J-18808-Ljbffr The Fountain Group