Veeva RIM Specialist

Role: Veeva RIM Specialist supporting regulatory document management for a biotech company developing immunotherapies and cell therapies, including FDA Breakthrough therapies like ANKTIVA. Responsibilities: manage and upload regulatory submissions (INDs, BLAs, CTAs) within Veeva RIM, maintain inspection-ready systems, track correspondence and meetings, assist in audits/inspections, configure Veeva Vault workflows, and support system validation and upgrades. Collaborate with Regulatory Affairs, IT, and clinical teams; train staff and provide ongoing support. Qualifications: Bachelor's in life sciences or technical field with 4+ years regulatory operations experience or 8+ years with a high school diploma; extensive hands-on Veeva RIM and Vault experience; familiarity with global regulatory submissions and health authority procedures preferred. HighValue: experience with electronic document management systems, GxP compliance, and working in a regulated biotech environment. Work setup: onsite in Summit, NJ, Monday–Friday, with some flexibility; involves long periods of computer work and collaboration with cross-functional teams.