RC-REGULATORY COMPLIANCE-Regulatory - SME-Senior Manager

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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Senior Manager – Regulatory Affairs   At EY, we’re all in to shape your future with confidence.   We’ll 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, you’ll 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 Senior Manager – 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 Deep understanding of regulations and guidelines, including ICH E2E, FDA, EMA, IDMP Modules, PMS and other international standards Support clients in interactions with health authorities, including responding to queries and managing regulatory communications. Participate in business development activities, including proposals, client presentations, and thought leadership in regulatory affairs. Ensure technology strategy alignment, including Regulatory systems and safety database systems and automation solutions. Build strong internal relationships within Risk Consulting and across service lines to deliver integrated solutions. Engage with client stakeholders, understand their challenges, and propose innovative digital solutions in the RA space that enhance compliance and efficiency. Contribute to business development, proposals, client presentations, and regulatory thought