RC-REGULATORY COMPLIANCE-BA-Senior

EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Senior- Business Analyst (Life Sciences IT Systems)

At EY were all in to shape your future with confidence.

Well 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 line with our commitment to quality youll 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 seeking an experienced Business Analyst with strong consulting skills and domain knowledge in Life Sciences IT systems to support regulatory clinical safety lab and manufacturing-related technology implementations. This role focuses on requirements gathering workflow design validation documentation and data migration planning for IT solutions in regulated GxP environments.

Role Overview

As a Business Analyst you will work closely with cross-functional teams to translate business needs into functional specifications lead workshops support system validation and ensure compliance with global regulatory standards. You will contribute to projects involving Regulatory/ Clinical/ Safety/ QMS/ LIMS/ ERP/ and Manufacturing systems enabling successful IT implementations in highly regulated environments.

Your key responsibilities

• Gather analyze and document business requirements for regulatory clinical safety lab and manufacturing IT systems.
• Lead workshops with stakeholders for requirements gathering as-is/to-be process analysis workflow design and data mapping between legacy and new systems.
• Develop data migration strategies including field mapping transformation rules and validation of migrated data.
• Design workflows process maps and functional specifications aligned with business objectives.
• Collaborate with technical teams to ensure accurate translation of requirements into system configurations.
• Support creation of validation documentation (e.g. Validation Plan URS FRS IQ/OQ/PQ Validation Report) and ensure compliance with GxP and CSV/CSA guidelines.
• Facilitate requirement traceability and manage UAT planning and execution using tools like qTest ALM and JIRA.
• Create dashboards and reports to track progress risks and testing outcomes.
• Act as a liaison between business and technology teams driving clarity and alignment on deliverables
• Support business development initiatives including assisting senior management with client pursuits proposals and RFP responses.

Qualifications:

• Bachelors degree in computer science Information Technology Life Sciences or a related field.
• 47 years of experience as a Business Analyst in IT projects within regulated environments.
• Business process expertise with Life Sciences systems such as QMS LIMS ERP MES or Safety platforms.
• 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

• Proven experience in requirements gathering and documentation using tools like JIRA Confluence ALM Lucid Visio Mural etc.
• Strong understanding of GAMP 5 methodology System Development Life Cycle (SDLC) and validation planning
• Proficiency in testing and validation tools such as qTest and ALM with strong dashboarding and reporting capabilities.
• Ability to collaborate with cross-functional teams (QA IT Manufacturing Labs Safety Regulatory)
• Experience in client-facing roles managing expectations and delivering solutions
• Strong communication and presentation skills
• Experience in IT project management and validation planning
• Familiarity with change control deviation handling and CAPA processes
• Proven ability to mentor junior resources
• Experience in training and cross-skilling resources
• Strong teamwork and collaboration mindset

Good-to-Have Skills & Attributes

• Exposure to business development activities and client engagement strategies
• Exposure to regulatory compliance (FDA EMA) and audit remediation.
• Ability to create innovative insights and contribute to thought leadership
• Experience in process optimization and operational efficiency initiatives
• Ability to align technology with business transformation goals
• High attention to detail and analytical thinking
• Adaptability to changing regulatory and business environments
• Strong problem-solving and decision-making abilities

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.