CMC Regulatory Affairs Associate II - Global Submissions

Job Summary Advance your career with a Top-Tier Global Pharma Leader in North Chicago, IL! This exciting 2-year hybrid contract role as a Regulatory Affairs Associate II offers the opportunity to drive CMC regulatory strategies and prepare high-impact submission dossiers for globally life-changing products. location: North Chicago, Illinois job type: Contract salary: $35.00 - 41.49 per hour work hours: 9 to 5 education: Bachelors Responsibilities Prepare and assemble CMC regulatory filing dossiers, including new applications, amendments, renewals, and variations. Assess manufacturing change control requests for regulatory impact and approve changes under management guidance. Collaborate with technical teams to analyze data and address global regulatory information requests. Manage regulatory documentation systems to ensure compliance and audit-readiness. Represent CMC Regulatory Affairs on cross-functional teams, including Global Regulatory Product Teams and Operations Brand Teams. Qualifications Required: Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or a related scientific field. 2-4 years of direct CMC regulatory experience in the pharmaceutical industry. Hands-on experience with quality systems or cross-functional project management in a complex, matrixed environment. Strong written and oral communication skills. Preferred US/EU post-approval variation support and international regulatory strategy experience. Hands-on experience with change management systems. skills: Investigational New Drug (IND), Chemistry Manufacturing and Controls (CMC) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on click.appcast.io. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. #J-18808-Ljbffr Randstad USA