RC-REGULATORY COMPLIANCE-BA-Senior

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.

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 :

Must-Have Skills & Attributes

Good-to-Have Skills & Attributes

What we look for

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 :

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.

Key Skills

Compliance Management,Risk Management,Financial Services,PCI,Banking,Cost Accounting Standards,Quality Systems,Research Experience,NIST Standards,Securities Law,SOX,ISO 27000

Employment Type : Full Time

Experience : years

Vacancy : 1