Regulatory Systems Manager (RIM / eCTD)
Join a leading biopharma company driving critical initiatives in Regulatory Systems and Global Submission Management. We're seeking a detail-oriented consultant with hands-on expertise in RIM tools, eCTD submission oversight, and regulatory process optimization. This role sits at the intersection of Reg Ops, Tech Systems, and Process Excellence, supporting global teams through system implementation, documentation, and training.
Key Focus Areas
- Regulatory Systems expertise (e.g., Veeva Vault RIM, InSight, Docubridge, CARA)
- Global eCTD submission process management
- SOP/SOW development, workflow mapping, and UAT testing
- Cross-functional collaboration with Regulatory, IT, and QA teams
- End-user training and tool support across global teams
- Solid understanding of Health Authority guidelines related to submission technologies
location: Chicago, Illinois
job type: Contract
salary: $60.00 - 64.12 per hour
work hours: 9 to 5
education: No Degree Required
responsibilities:
What you'll do
- Support eCTD submissions across global development and lifecycle programs
- Provide oversight of outsourced publishing activities (not hands-on publishing)
- Lead drafting/review of process docs, SOPs, SOWs, and UAT testing
- Collaborate with Regulatory, IT, and cross-functional teams on new tool rollouts
- Conduct end-user training and systems support (Veeva, InSight, Docubridge, CARA)
- Ensure alignment with global Health Authority tech guidelines
qualifications:
Required:
- 3-5 years of experience in regulatory operations with experience in Regulatory systems and submissions.
- Regulatory Systems experience (ie, InSight, Veeva, Docubridge, CARA) and submissions process knowledge is essential.
- Experience with drafting and review of process documents, mapping, SOW documentation, and UAT testing.
- Experience of working closely with global IT and cross functional stakeholders to implement training and support to end users for new systems, tools and applications.
- Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Briefing Documents, Submissions
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
