Join EY's GDS Consulting – Enterprise Risk team as a Regulatory Compliance Manager, specializing in Veeva RIM. This role offers an opportunity to lead impactful digital quality initiatives within the pharmaceutical sector. We are seeking professionals with deep platform expertise, leadership capabilities, and consulting acumen, ideally with experience in regulated, client-facing environments. If you are passionate about technology-driven transformation and mentoring teams, this is the perfect fit.

As a key member of our team, you will contribute to shaping the future with confidence, leveraging EY's global network to advance your career. You will work with diverse teams and help build a better working world.

Oversee the design, configuration, and deployment of Veeva Vault RIM applications across enterprise settings. Lead cross-functional collaboration, manage client relationships, and ensure regulatory compliance. You will guide development teams, provide strategic consulting, and optimize processes to align Vault capabilities with business transformation goals.

Key duties include leading configuration and customization of Vault RIM (Registrations, Submissions, Archive), architecting workflows and security models, and directing RIMS implementation projects. You will also engage with stakeholders to translate requirements, manage data migration, and ensure system compliance with GxP, CSV/CSA, and 21 CFR Part 11.

A Bachelor's degree in Computer Science, Information Technology, or a related field is required. We are looking for 8-12 years of experience in regulatory areas, with 3-5 years specifically in Veeva Vault RIMS configuration and development. Deep expertise in Regulatory Affairs and Regulatory Information Management systems is essential.

Candidates must possess strong knowledge of global regulatory frameworks (FDA, EMA, ICH), GAMP 5, and SDLC in validated environments. Excellent communication, client interaction, and analytical skills are crucial. Familiarity with electronic submission standards (eCTD, NeeS) and data standards (IDMP, xEVMPD) is also expected. An understanding of Registrations, Submissions, Submission Planning, and Archive processes within regulated environments is vital.