RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior

EY- GDS Consulting - Enterprise Risk (ER) - Regulatory Compliance - Senior - Veeva - Regulatory/Safety

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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 RIM and PV 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/PV Configuration specialist, you will lead the design, configuration, and deployment of Veeva Vault RIM and Pharmacovigilance applications 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 and PV 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.
• 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.

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

• 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.
• 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 engagement skills.
• Experience in IT project management, including planning, execution, and validation strategy development.
• Strong analytical skills to troubleshoot application issues, perform impact assessments, and recommend scalable solutions.
• In-depth understanding of Registrations, Submissions, Submission Planning, Archive process within regulated environments.
• Thorough understanding of Regulatory Intelligence, Quality in Digital, submission management and archival, and document management processes within regulated environments.
• Proven ability to mentor and lead junior team members, fostering technical growth and collaboration.
• Experience in training and cross-skilling resources, enabling team agility and knowledge sharing.
• A collaborative mindset with a focus on teamwork, innovation, and continuous improvement.
• Veeva Associate Administrator Certification and/or equivalent platform credentials.

Good-to-Have Skills & Attributes

• Experience with Vault Safety integrations or legacy PV systems (e.g., Argus).
• Exposure to business development activities, including client engagement, proposal support, and solutioning.
• Solid understanding of GxP regulations, including FDA 21 CFR Part 11 and EU Annex 11.
• Ability to contribute to thought leadership, offering innovative insights and best practices in Vault implementation.
• Experience in process optimization and operational efficiency initiatives, aligning technology with business outcomes.
• Strategic mindset with the ability to align Vault capabilities with digital transformation goals.
• High attention to detail, with strong analytical and critical thinking skills.
• Adaptability to evolving regulatory landscapes and business priorities.
• Strong problem-solving and decision-making abilities in complex, fast-paced environments.

Ideally, you'll also have

• CSQE, CSQA, or equivalent quality certifications
• ISO 9001:2015 Lead Auditor or CQA
• Information Security or Risk Management certifications
• Advanced Veeva Vault RIM and/or Safety certifications

What working at EY offers

At EY, we're dedicated to helping our clients, from start-ups to Fortune 500 companies - and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• 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