Veeva Regulatory Business Analyst || Princeton, New Jersey(Hybrid)

Job Description

The individual will serve as a key liaison between business stakeholders, technical teams, vendors, and governance partners to deliver compliant, user-centered, inspection-ready solutions that improve process efficiency, data quality, and cross-functional visibility.

Experience

• 7+ years of experience in product ownership, business analysis, systems analysis, or technology delivery within regulated environments.
• Experience supporting PLM, QMS, Regulatory Information Management, document management, workflow, or enterprise quality/regulatory platforms. Must have hands on experience with Veeva Vault RegulatoryOne, Product Lifecycle Management and Quality Management Systems.
• Strong understanding of product development, specification management, change control, quality events, CAPA, audits, complaints, submissions, registrations, claims, or regulatory documentation processes.
• Experience working with cross-functional teams across R&D, Quality, Regulatory, Operations, IT, and external vendors.
• Experience supporting validated systems, inspections, audits, and regulated technology delivery preferred.

Technical Skills

• Strong knowledge of Agile, hybrid delivery, SDLC, backlog management, user story writing, acceptance criteria, and release planning.
• Hands-on experience documenting business requirements, process maps, workflows, data flows, test cases, validation artifacts, and traceability matrices.
• Working knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, data integrity, audit trails, electronic records/signatures, and change control expectations.
• Familiarity with PLM, QMS, RIM, document management, reporting, analytics, integration, and workflow automation tools.
• Experience with tools such as Jira, Azure DevOps, ServiceNow, Power BI, Visio, Miro, SharePoint, or similar platforms.

Must Have

• Veeva
• Regulatory (does not have to be an expert in regulations)
• Regulatory Information Management System with Veeva
• Bolt on module (lower level from Veeva)
• 50 global users

Preferred

• Business Analyst that has a regulatory (Veeva Specific) background – No current expertise on team with Regulatory/Veeva background
• Needs someone who really knows the system
• Work with vendor to implement and integrate
• Roll up sleeves and get dirty
• Thinking someone 10 years in as a BA, growing into a Product Owner
• Long term vision for the role would be to turn this into a product owner, will own the Regulatory, Veeva, QMS tracks
• Needs leadership experience, but person has to be in the weeds on project
• Veeva will be doing the implementation themselves