EY

Senior Regulatory Compliance

EY

full-time

Posted on:

Location Type: Office

Location: Bengaluru • India

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Job Level

Senior

Tech Stack

SDLCVault

About the role

  • 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.
  • Deep understanding of PV regulations and guidelines, including ICH E2E, FDA, EMA, GVP Modules, and other international standards.
  • Oversee end-to-end PV operations, including case intake, processing, case triaging, medical review, signal detection, risk management, and aggregate reporting
  • 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 PV systems (e.g., Argus, E2B gateways, clinical systems).
  • Ensure compliance with global safety regulations including FDA, EMA, ICH (E2B, E2C, E2D), and regional pharmacovigilance 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 and PV 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.

Requirements

  • 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.
  • 6-9 years of hands-on experience in regulatory area with around 3-5 years of experience in Veeva Vault RIMS and PV configuration and development, with deep expertise in Regulatory Affairs and Regulatory information management system.
  • Strong knowledge of global regulatory and safety frameworks, including FDA, EMA, ICH guidelines, and regional PV 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.
  • Proven success in client-facing roles, managing stakeholder expectations and delivering tailored Vault solutions.
  • Experience in IT project management, including planning, execution, and validation strategy development.
  • Veeva Associate Administrator Certification and/or equivalent platform credentials.
Benefits
  • Support, coaching and feedback from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for you
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Veeva Vault RIMconfigurationcustomizationdata migrationintegrationAgileScrumGxP complianceCSV/CSA methodologiesSystem Development Life Cycle (SDLC)
Soft Skills
analytical abilitiesproblem-solvingcommunicationclient interactiondocumentationleadershipmentoringcollaborationcontinuous improvementstakeholder management
Certifications
Veeva Associate Administrator Certification