RC-REGULATORY COMPLIANCE-BA-Staff

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.

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – BA - Staff

The opportunity

We are looking for a proactive and detail-oriented Staff Consultant – Business Analyst to support Computerized System Validation (CSV) and Regulatory IT initiatives across global pharmaceutical clients. This role offers hands-on experience with validated systems such as Veeva Vault QMS, TrackWise, SAP, LIMS, ELN, MES, and Regulatory Information Management Systems (RIMS). You'll contribute to requirement gathering, validation documentation, and business transformation programs while collaborating with cross-functional teams in a regulated environment.

Your Key Responsibilities

• Assist in requirements elicitation, documentation, and stakeholder communication for IT systems in scope.
• Contribute to CSV activities using GAMP 5 Life Cycle methodology.
• Support gap assessments and remediation for legacy systems to align with current validation policies.
• Participate in software classification, risk assessments, and mitigation planning.
• Collaborate with QA, IT, and business teams to troubleshoot application-related issues and recommend solutions.
• Support business process transformation programs involving systems like Veeva Vault QMS, TrackWise, SAP, LIMS, ELN, MES, Documentum, ValGenesis, Argus, and RIMS.
• Support in validation deliverbales.
• Contribute to audit readiness and documentation for inspections and compliance reviews.
• Maintain strong client relationships and support internal initiatives and knowledge sharing.
• Stay updated on industry trends, regulatory changes, and EY service offerings.
• Participate in cross-skilling and training programs to enhance domain and technical capabilities.

Skills And Attributes For Success

Good-to-Have Skills

To qualify for the role, you must have

What We Look For

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 :

EY | Building a better working world

EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets.

Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.

EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.

Skills Required

Sap, trackwise , Lims, eln , Documentum, Regulatory Affairs, Qms, Pharmaceutical Quality Control, Argus, Mes, Quality Assurance