EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Senior – Regulatory Affairs

At EY, we’re all in to shape your future with confidence.

We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world.

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 specialist with Regulatory Affairs experience to lead high-impact digital quality initiatives within the pharmaceutical domain. This opportunity is ideal for professionals who blend deep process 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 Regulatory Affairs Business Analyst, you will lead the design, help in requirements, testing and deployment of 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 RIM capabilities with broader business transformation goals while mentoring and guiding a team of Vault developers and analysts.

Your key responsibilities

• Lead the requirements, design and deployment of RIM Platforms (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 RIM, and external 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.
• Act as a strategic consultant to internal and external stakeholders, advising on RIM 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:

• Bachelor’s degree in computer science, Information Technology, or a related technical discipline.
• Proven proficiency in Regulatory Affairs business process and platform components including objects, fields, roles, workflows, lifecycles, and reporting tools.
• Experience working in Agile/Scrum environments, contributing to iterative development and continuous improvement.
• 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 RIM platforms, 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 RIMS systems
• 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 Platform 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