RC - REGULATORY COMPLIANCE - Veeva RIM - CA - Senior

EY

6–9 yrs Pune Full Time Hybrid (office + remote)
EY logo
Posted : today
Actively hiring

Job description

Join EY's GDS Consulting team as a Senior Regulatory Compliance specialist, focusing on Veeva Vault RIM configuration. This role is crucial for leading high-impact digital quality initiatives within the pharmaceutical sector. You will leverage your deep platform expertise, leadership skills, and consulting acumen to drive transformation in regulated, client-facing environments. If you're passionate about technology-driven change and team mentorship, this is an exceptional opportunity to build a unique career.

Responsibilities

As a Veeva Vault RIM Configuration Specialist, you will spearhead the design, configuration, and deployment of Veeva Vault RIM applications. This involves managing cross-functional collaborations with Regulatory Affairs, Drug Safety, Quality, IT, and Business teams, ensuring global regulatory and safety compliance. You will also act as a strategic consultant, aligning Vault RIM capabilities with business transformation goals and mentoring a team of Vault developers and analysts. Key duties include leading configuration and customization, architecting workflows and lifecycles, overseeing RIMS implementation, supporting integrations, ensuring compliance with global regulations, engaging with stakeholders, directing data migration, establishing system documentation, leading issue resolution, managing release cycles, and advising on digital transformation initiatives.

Qualifications

We are seeking a Bachelor's degree holder in Computer Science, Information Technology, or a related technical field. Essential qualifications include proven proficiency in configuring the Veeva Vault platform, familiarity with Veeva APIs and integration tools, and experience in Agile/Scrum environments. A strong understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 is required. Candidates must possess excellent analytical, problem-solving, communication, client interaction, and documentation skills. A minimum of 6-9 years of experience in the regulatory area, with 3-5 years focused on Veeva Vault RIMS configuration and development, is mandatory. Deep expertise in Regulatory Affairs and Regulatory Information Management is critical.

Essential Skills

Veeva Vault RIM ConfigurationRegulatory Information Management System (RIMS)GxP ComplianceCSV/CSA Methodologies21 CFR Part 11FDAEMAICH GuidelinesGAMP 5System Development Life Cycle (SDLC)Agile/ScrumClient Relationship ManagementStakeholder EngagementIT Project ManagementProblem-SolvingAnalytical SkillsTechnical DocumentationIssue ResolutionImpact AnalysisChange ManagementMentoringTeam LeadershipVeeva APIsVeeva Vault LoaderElectronic Submission Standards (eCTDNeeS)Data Standards (IDMPxEVMPD)

Good to Have

Veeva Associate Administrator CertificationIntegrations with Different Veeva VaultLegacy System IntegrationBusiness DevelopmentEU Annex 11Thought LeadershipProcess OptimizationOperational EfficiencyDigital TransformationCSQECSQAISO 9001:2015 Lead AuditorCQAInformation Security CertificationsRisk Management CertificationsAdvanced Veeva Vault Platform CertificationsAdvanced Veeva RIM Certifications

Highlights

  • Actively hiring

More Details

RoleRC - REGULATORY COMPLIANCE - Veeva RIM - CA - Senior
IndustryManagement Consulting, Information Technology & Services, Pharmaceuticals
DepartmentInformation Technology, Regulatory Affairs
Employment TypeFull Time, Hybrid (office + remote)

About the Company

EY Global Delivery Services ( EY GDS) logo

EY Global Delivery Services ( EY GDS)

Management Consulting

RC - REGULATORY COMPLIANCE - Veeva RIM - CA - Senior at EY | SkillMX | SkillMX