Are you a detail-oriented regulatory professional with strong technical project management skills? Join a global pharmaceutical leader in North Chicago, IL, on a hybrid schedule. In this high-visibility execution role, you will act as a Technical Project Manager, coordinating post-approval changes and compiling essential Chemistry, Manufacturing, and Controls (CMC) dossier content to ensure seamless regulatory filings.
location: North Chicago, Illinois
job type: Contract
salary: $29.00 - 32.29 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Manage, compile, and author CMC Module 3 content and submission dossiers for marketed product variations.
- Partner closely with RA CMC Project Leads to establish project timelines and ensure the accurate gathering of home-source documentation.
- Interface with cross-functional subject matter experts (SMEs) and facilitate project review meetings to keep filings on schedule.
- Maintain strict adherence to eCTD, ICH structures, and international regulatory formatting standards.
- Track project scope, business objectives, and team feedback, proactively adjusting priorities and timelines as necessary.
qualifications:
Required:
- Bachelor's or Master's degree in Chemical, Biological Sciences, or a related discipline.
- 1-2 years of pharmaceutical industry experience with direct exposure to CMC/Module 3 content.
- Hands-on familiarity with eCTD structures and regulatory submission requirements.
- Proven project management experience with strong cross-functional communication abilities.
- Background in process development or analytical functions with regulatory document authoring experience.
- Experience using electronic document management systems (EDMS).
skills: FDA Submissions, Chemistry Manufacturing and Controls (CMC), Electronic Common Technical Document (eCTD), eRegulatory (eReg)
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.
