job summary:
Looking to advance your regulatory career in biopharma? A Top-Tier Global Biopharmaceutical Leader in North Chicago, IL is seeking a Regulatory Affairs Associate II for an immediate 6-month contract!
This opportunity offers a balanced Hybrid schedule (On-site Tuesday–Thursday; Remote Monday/Friday).
We are seeking a detail-driven professional with 1–2 years of industry experience and a solid foundation in CMC documentation to support high-priority global submissions.
location: North Chicago, Illinois job type: 6 month contract salary: $30.00 - 34.57 per hour work hours: 9:00am to 5:00pm education: Bachelors degree
responsibilities:
- Author, review, and compile submission-ready Chemistry, Manufacturing, and Controls (CMC) documentation.
- Utilize Electronic Document Management Systems (EDMS), specifically Veeva Vault, to manage, archive, and route regulatory files.
- Ensure documentation aligns with relevant ICH guidelines and global regulatory standards.
- Collaborate closely with cross-functional technical teams to rapidly resolve document discrepancies and meet submission milestones.
- Maintain rigorous version control and compliance tracking across ongoing regulatory projects.
qualifications:
required:
- Bachelor’s degree in Life Sciences, Chemistry, or a related scientific discipline.
- 1–2 years of experience within biopharma or pharmaceutical development with direct CMC exposure.
- Working knowledge of ICH guidelines and regulatory documentation standards.
- Hands-on proficiency using EDMS platforms (Veeva Vault preferred).
- Demonstrated ability to articulate current and past technical project experience clearly.
- Ability to work on-site in North Chicago, IL, Tuesday through Thursday.
preferred:
- Prior regulatory affairs experience in pharma or biotech.
skills:regulatory submissions, cmc, veeva vault
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 HRsupport@randstadusa.com.
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.