RC-REGULATORY COMPLIANCE-BA-Manager

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

The opportunity

We are seeking an experienced Manager – Business Analyst with strong consulting skills and domain expertise in Life Sciences IT systems to lead regulatory, clinical, safety, lab, and manufacturing-related technology implementations. This role combines process expertise, solutioning, delivery leadership and stakeholder engagement to drive successful outcomes in regulated GxP environments.

Role Overview

As a Manager, you will own client relationships, lead teams of analysts, and ensure high-quality delivery of IT implementation projects. You will guide requirements definition, process optimization, validation planning, and data migration / integration strategies, while also supporting senior leadership in client pursuits and RFP responses. This role demands strong consulting acumen, ability to manage complex programs, and a focus on operational excellence

Your Key Responsibilities

• Lead end-to-end delivery of Business Analysis workstreams across regulatory / clinical / safety / lab / manufacturing IT systems.
• Drive solutioning activities, ensuring alignment of technology capabilities with business objectives and compliance requirements.
• Provide process expertise across Life Sciences business processes, including R&D, Clinical, Regulatory, and Quality workflows, and translate these into system requirements.
• Lead workshops for as-is / to-be analysis, workflow design, and data mapping between legacy and new systems.
• Oversee data migration and system integration planning, ensuring alignment with business processes and compliance requirements.
• Provide strategic guidance on validation planning and execution, including authoring and reviewing documentation (Validation Plan, URS, FRS, IQ / OQ / PQ, Validation Report).
• Manage requirement traceability and testing governance using tools like JIRA, Confluence, qTest, and ALM.
• Develop dashboards and reporting frameworks for project performance, risks, and compliance tracking.
• Act as a trusted advisor to clients, ensuring stakeholder alignment and managing expectations at senior leadership levels.
• Mentor and coach junior team members, fostering a culture of collaboration and continuous improvement.
• Support business development initiatives by assisting with client pursuits, drafting RFP responses, and delivering impactful presentations in collaboration with senior leadership.
• Contribute to thought leadership and internal capability-building initiatives within the Regulatory Compliance practice.

Qualifications :

Must-Have Skills & Attributes

Good-to-Have Skills & Attributes

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

Alm, Qtest, Csv, Agile Methodologies, Jira, Sdlc, Confluence