job summary: We are seeking a Regulatory Systems Manager (RIM/eCTD) to support global regulatory operations through expert oversight of RIM tools, eCTD submissions, and process improvement initiatives. This role bridges Regulatory Operations, Technology, and Process Excellence, driving the implementation, documentation, and training of regulatory systems across global teams. We are looking for someone who has experience overseeing publishing vendors. Fully remote role. location: Telecommute job type: Contract salary: $60.00 - 64.12 per hour work hours: 9 to 5 education: No Degree Required responsibilities: Support eCTD submissions across global development and lifecycle programsProvide oversight of outsourced publishing activities (not hands-on publishing)Lead drafting/review of process docs, SOPs, SOWs, and UAT testingCollaborate with Regulatory, IT, and cross-functional teams on new tool rolloutsConduct end-user training and systems support (Veeva, InSight, Docubridge, CARA)Ensure alignment with global Health Authority tech guidelines qualifications: Required: 3+ years of experience supporting regulatory submissions for the US and EU, with strong knowledge of eCTD submission processes.Proficiency with regulatory systems such as Veeva, InSight, Docubridge, or CARA.Experience drafting process documents (SOPs, SOWs, mapping), conducting UAT testing, and collaborating with global IT and cross-functional teams.Experience overseeing publishing vendors #LIAB1 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: 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. 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.