Regulatory Affairs Associate II

job summary: Advance your regulatory career in North Chicago with a top-tier global pharmaceutical leader. We are seeking a detail-oriented Regulatory Affairs Associate II to manage, compile, and author Chemistry, Manufacturing, and Controls (CMC) submission sections for marketed product variations. In this hybrid role, you will collaborate with cross-functional teams to ensure timely and compliant regulatory filings. location: North Chicago, Illinois job type: Contract salary: $30.00 - 34.57 per hour work hours: 9 to 5 education: Bachelors responsibilities:

Author, compile, and manage Module 3 CMC sections and CTD content for marketed product variations with minimal supervision. Manage assigned project timelines to ensure accuracy, thoroughness, and on-time submission of dossiers and agency responses. Independently facilitate cross-functional project team and submission review meetings. Review and approve manufacturing changes, engineering study protocols/reports, and validation protocols/reports. Prepare and submit PMA supplements (including 30-day Notices, Real-Time Reviews, 180-day Supplements, and Annual Reports). Maintain awareness of regulatory business systems and current best practices to optimize submission workflows.

qualifications:

Required: Minimum BA/BS degree in Chemical, Biological Sciences, or a relevant discipline. 4+ years of pharmaceutical industry experience. 1-2 years of cross-functional project management experience. Strong familiarity with CTD Module 3 structural and formatting requirements. Proven ability to manage multiple projects independently in a fast-paced environment. Preferred: 5 years of pharmaceutical experience, including 1-2 years in Regulatory Affairs, R&D, or Manufacturing. Direct experience authoring and submitting PMA supplements for Class III implantable medical devices. #LI-MH1 skills: Electronic Common Technical Document (eCTD)

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.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. 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.