RC-REGULATORY COMPLIANCE-Regulatory - CA-Manager

Job Summary

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines methodologies. As a Regulatory Compliance senior, actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you'll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The Opportunity

We are looking for a seasoned and strategic Veeva Vault RIM Manager to lead high-impact digital quality initiatives within the pharmaceutical domain. This opportunity is ideal for professionals who blend deep platform expertise with leadership and consulting acumen, and who thrive in regulated, client-facing environments. If you're passionate about driving transformation through technology and mentoring high-performing teams, this role is for you.

Role Overview

As a Veeva Vault Manager, you will oversee the design, configuration, and deployment of Vault Regulatory application (RIM) across enterprise environments. You will lead cross-functional collaboration, lead calls with business stakeholders, manage client relationships, and ensure regulatory compliance while guiding a team of developers and analysts. Your role will also involve strategic consulting, process optimization, and aligning Vault capabilities with broader business transformation goals.

Your key responsibilities

• Lead the configuration, customization, and deployment of Veeva Vault RIM (Registrations, Submissions, Submission Planning, Archive), ensuring alignment with pharmaceutical quality standards and regulatory frameworks.
• Architect and oversee the development of workflows, object lifecycles, security models, and page layouts, enabling scalable and compliant Vault implementations.
• Lead RIMS implementation projects, ensuring seamless integration with other enterprise systems and compliance with data standards (e.g., IDMP, xEVMPD).
• Engage with cross-functional stakeholders (Quality, Regulatory, IT, Business) to gather and translate complex requirements into functional and strategic Vault configurations.
• Direct data migration and integration initiatives, ensuring seamless connectivity between Veeva Vault and enterprise systems such as Clinical, QMS and other Document Management platforms.
• Establish and maintain comprehensive system documentation, including design specifications, configuration guides, validation protocols (IQ/OQ/PQ), and audit-ready deliverables.
• Provide leadership in issue resolution and impact analysis, guiding teams through troubleshooting and change management processes.
• Ensure system compliance with GxP, CSV/CSA, and 21 CFR Part 11 regulations, embedding validation best practices throughout the development lifecycle.
• Manage release cycles and testing activities, including sandbox coordination, regression testing, and production deployments.
• Act as a strategic consultant to internal and external stakeholders, advising on Vault capabilities, optimization opportunities, and digital transformation initiatives.
• Mentor and lead a team of Vault developers and analysts, fostering a culture of innovation, collaboration, and continuous improvement.

Qualifications

• Bachelor's degree in computer science, Information Technology, or a related technical discipline.
• Proven proficiency in configuring the Veeva Vault platform, including objects, fields, roles, workflows, lifecycles, and reporting tools.
• Familiarity with Veeva APIs, Vault Loader, and other integration tools for data migration and system interoperability.
• Experience working in Agile/Scrum environments, contributing to iterative development and continuous improvement.
• Solid understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements in validated environments.
• Strong analytical and problem-solving abilities, with excellent communication, client interaction, and documentation skills.

Must-Have Skills Attributes

• Veeva Vault RIMS configuration and development
• Extensive knowledge of global regulatory frameworks, including FDA, EMA, ICH guidelines, and regional requirements
• GAMP 5 methodology and the System Development Life Cycle (SDLC)
• Electronic submission standards (eCTD, NeeS) and data standards (IDMP, xEVMPD)
• Client-facing roles, stakeholder management
• IT project management, planning, execution, and validation strategy development
• Registrations, Submissions, Submission Planning, Archive process
• Regulatory Intelligence, Quality in Digital, submission management and archival, and document management
• Veeva Associate Administrator Certification

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.