Veeva Vault Regulatory Business Analyst

Job Title: Veeva Vault Regulatory Business Analyst
Location: Ewing, NJ – Hybrid (3 Days Onsite / Week)
 

Job Summary

We are seeking an experienced Technical Business Analyst / Product Owner to support the strategy, roadmap, and delivery of digital solutions across Product Lifecycle Management (PLM), Quality Management Systems (QMS), and Regulatory processes within a highly regulated global R&D environment.

The ideal candidate will have strong hands-on experience with Veeva Vault RegulatoryOne, PLM, and QMS platforms, along with a solid understanding of regulated business processes, Agile delivery, validation, and compliance requirements. This role will partner closely with business stakeholders, IT teams, and technology vendors to deliver scalable, compliant, and user-focused solutions.

Key Responsibilities

• Own and manage the product roadmap, backlog, priorities, and delivery activities for PLM, QMS, and Regulatory platforms.
• Gather, analyze, document, and translate business requirements into detailed user stories, process flows, functional requirements, and acceptance criteria.
• Partner with business stakeholders, IT teams, product teams, and external vendors to design, implement, enhance, and support digital solutions.
• Support regulated R&D, Quality, and Regulatory processes, including:
  • Product Lifecycle Management
  • Change Control
  • CAPA
  • Deviations
  • Audits
  • Complaints
  • Regulatory Documentation
• Lead and coordinate testing activities including SIT, UAT, validation, defect management, and production releases.
• Ensure solutions and delivery processes align with SDLC, Agile, GxP, FDA 21 CFR Part 11, and Computer System Validation (CSV) requirements.
• Collaborate with validation and quality teams to prepare and maintain required validation documentation.
• Analyze user feedback, adoption metrics, and platform performance to identify opportunities for continuous improvement.
• Facilitate stakeholder meetings, requirements workshops, backlog grooming, sprint planning, and solution reviews.
• Translate complex regulatory and business requirements into scalable and technically feasible solutions.
• Support production issues, enhancements, releases, and ongoing platform optimization.

Required Qualifications

• 12+ years of experience as a Product Owner, Business Analyst, Technical Business Analyst, or Systems Analyst.
• Hands-on experience with Veeva Vault RegulatoryOne is required.
• Strong experience with Veeva Vault, Product Lifecycle Management (PLM), and Quality Management Systems (QMS).
• Experience supporting regulated R&D, Quality, Regulatory, Pharmaceutical, Biotech, or Life Sciences organizations.
• Strong understanding of Agile methodologies, Scrum, backlog management, requirements gathering, and software delivery lifecycle.
• Experience creating business requirements, functional requirements, user stories, process flows, and acceptance criteria.
• Strong experience with Computer System Validation (CSV), GxP, FDA 21 CFR Part 11, and validation documentation.
• Experience leading SIT, UAT, defect resolution, validation testing, and production releases.
• Strong stakeholder management and cross-functional collaboration experience.

Preferred Skills

• Experience working with Jira, Azure DevOps, ServiceNow, Power BI, Visio, and SharePoint or similar tools.
• Experience with Veeva Vault implementations, enhancements, integrations, or migrations.
• Strong knowledge of Regulatory, Quality, and Product Lifecycle business processes.
• Experience working with global R&D organizations and geographically distributed teams.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively in a fast-paced and highly regulated environment.

Education

Bachelor’s degree in Computer Science, Information Technology, Business, Life Sciences, or a related field is preferred.