RC-REGULATORY COMPLIANCE-Regulatory - BA-Manager 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 Manager Regulatory Affairs BA 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 Manager actively establish, maintain and strengthen internal and external relationships. In 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 Manager with deep expertise in Regulatory Affairs to lead regulatory strategy and IT-enabled transformation initiatives in regulated GxP environments. This role requires strong consulting skills, industry knowledge, and the ability to translate regulatory strategy into scalable, compliant solutions for global clients.

Role Overview As a Manager at Regulatory Compliance, you will lead IT implementation projects in regulated GxP environments, leveraging your deep expertise in Regulatory Affairs and Regulatory Information Management Systems (RIMS) and strong consulting capabilities.



Your primary responsibility will be to partner with clients to understand their business needs and translate strategic objectives into innovative, practical solutions. You will play a pivotal role in establishing and nurturing relationships across internal teams and external stakeholders, ensuring alignment with our commitment to quality and compliance.

This is a leadership role that demands strategic thinking, relationship-building, and a passion for delivering excellence in a highly regulated environment. Your key responsibilities Client Responsibilities Lead global regulatory strategy development, ensuring compliance with FDA, EMA, MHRA, PMDA, and other health authorities Provide expert guidance on regulatory submissions, dossier preparation, and lifecycle management across multiple markets Drive RIMS implementation and optimization (e.g., Veeva Vault RIM) to improve data integrity and regulatory efficiency Design regulatory roadmaps aligning processes, technology, and operating models Support health authority interactions, responses to queries, and regulatory communications Identify opportunities for process standardization, automation, and digital enablement within regulatory operations Engage client stakeholders to propose creative regulatory and digital solutions Contribute to business development, proposals, client presentations, and regulatory thought leadership Stay current with changing regulatory requirements,



assess impacts, and advise proactive client strategies People Responsibilities Develop people through effective coaching and mentoring Conduct performance reviews and contribute to performance feedback Contribute to people-related initiatives including recruiting, retaining, appraisal and training Contribute towards building and strengthening team competency for Regulatory Compliance and Risk consulting Participate in the organization-wide people initiatives Maintain an educational program to develop skills of team members continually Decision-Making Responsibilities: Support management in workforce planning, resourcing strategy, go to market strategy and demand generation Understand the business requirements clearly and lead practice development initiatives as required Developing and implementing strategic plans to help clients navigate complex regulatory environments. Overseeing project teams and ensuring that regulatory submissions and other deliverables are completed on time and within budget.

Building and maintaining relationships with key stakeholders, including regulatory agencies, clients, and industry groups. Bring out of the box thinking mindset, and analytical thinking capability to enhance service delivery Always maintain connections with clients to tap opportunities for constant growth and improvement Lead business growth, pursuits and client proposals for Enterprise Risk/Regulatory Compliance, directly working with the regional partners Directors and Senior Managers.

Other Responsibilities

Oversee regulatory operations / global pharmacovigilance programs, ensuring compliance with regulatory requirements and delivery within timelines and budgets Monitor global regulatory changes .

📌 Regulatory Compliance Manager (Bengaluru)
🏢 Ernst u0026 Young LLP ( EY India )
📍 Bengaluru