RC-REGULATORY COMPLIANCE-BA-Staff

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). Youll 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

• Experience in Quality & Compliance advisory within the Life Sciences domain.
• Experience working with Agile tools like JIRA and testing tools like qTest or HP ALM.
• Domain knowledge in Pharmaceutical Quality Control Quality Assurance and Regulatory Affairs.
• Understanding of CSV principles GAMP 5 and System Development Life Cycle (SDLC).
• Familiarity with global regulations: USFDA 21 CFR Part 11 EU GMP Annex 11 WHO HIPAA TGA MCC Anvisa.
• Exposure to enterprise IT systems: Veeva Vault QMS TrackWise SAP LIMS ELN MES Documentum ValGenesis Argus RIMS.
• Strong interpersonal documentation and presentation skills.

Good-to-Have Skills

• Strong Business Analyst (BA) capabilities: process mapping gap analysis stakeholder engagement and functional documentation.
• Exposure to business development and client engagement strategies.
• Experience supporting audits and inspections.
• Experience in process optimization and operational efficiency initiatives.
• Ability to align technology with business transformation goals.
• Analytical thinking adaptability and decision-making skills.

To qualify for the role you must have

• B.E/ (Electronics Telecommunications Computer Science) or
• Postgraduate in Science (preferably Chemistry/Biochemistry)
• 1-3 years of experience in a Big 4 or multinational life sciences organization
• Strong communication and collaboration skills
• Good interpersonal skills; Good written and presentational skills

What we look for

• A Team of people with commercial acumen technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading multi-disciplinary team of 1400 professionals in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY were dedicated to helping our clients from startups 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 thats right for you