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    Job · 21265782

    PUNE · FULLTIME

    RC - REGULATORY COMPLIANCE - Veeva RIM - CA - Senior

    Ernst Young

    Ernst Young

    Pune · onsite · Posted 5d ago

    Sourced fromNaukri
    Undisclosed6–9 yrsfulltimePune

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    Section · 01

    About this role

    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 Senior Configuration specialist with RIMS experience 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 RIM Configuration specialist, you will lead the design, configuration, and deployment of Veeva Vault RIM application across enterprise environments. You will manage cross-functional collaboration with Regulatory Affairs, Drug Safety, Quality, IT, and Business teams, oversee client relationships, and ensure compliance with global regulatory and safety requirements.
    You will also play a strategic consulting role, aligning Vault RIM capabilities with broader business transformation goals while mentoring and guiding a team of Vault developers and analysts.
    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).
    • Support integration and interoperability between Vault Safety, RIM, and external systems (e.g., Argus, E2B gateways, clinical systems).
    • Ensure compliance with global regulations including FDA, EMA, ICH (E2B, E2C, E2D), and regional regulatory requirements.
    • 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.
    • Engage with client stakeholders, understand their challenges, and propose innovative digital solutions in the RA space that enhance compliance and efficiency.
    • Mentor and lead a team of Vault developers and analysts, fostering a culture of innovation, collaboration, and continuous improvement.
    Qualifications
    • Bachelors 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
    • 6-9 years of hands-on experience in regulatory area with around 3-5 years of experience in Veeva Vault RIMS configuration and development, with deep expertise in Regulatory Affairs and Regulatory information management system.
    • Strong knowledge of global regulatory frameworks, including FDA, EMA, ICH guidelines, and regional market specific requirements.
    • Extensive knowledge of global regulatory frameworks, including FDA, EMA, ICH guidelines, and regional requirements.
    • Strong command of GAMP 5 methodology and the System Development Life Cycle (SDLC), with proven experience in validated environments.
    • Demonstrated ability to collaborate across cross-functional teams including QA, IT, Digital, Manufacturing, and Laboratory functions.
    • Familiarity with electronic submission standards (eCTD, NeeS) and data standards (IDMP, xEVMPD).
    • Proven success in client-facing roles, managing stakeholder expectations and delivering tailored Vault solutions.
    • Excellent communication, presentation, and stakeholder management skills.

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    Section · 02

    Skills

    AgileCfranalytical thinkingapisArgusdata standardsCSVChange ManagementcustomizationDigital SolutionsCapital MarketsdeploymentBusiness DevelopmentData MigrationBusiness TransformationDigital Transformationcompliance

    Section · Company

    About Ernst & Young

    Ernst Young

    Ernst Young

    Management Consulting

    44k+

    employees

    2002

    24 years old

    Gurgaon / Gurugram, Haryana

    India

    ₹15.3L PA avg

    Avg at Ernst & Young

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    At EY, our purpose is Building a better working world. The insights and quality services we provide help build trust and confidence in the capital markets and in economies the world over.

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