Veeva Vault RIM Expert – Regulatory Submissions

Stanley David and Associates

United States

On-site

USD 120,000 - 160,000

Full time

3 days ago
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Job summary

Stanley David and Associates is seeking an experienced Veeva RIM Consultant to lead regulatory information management initiatives in the pharmaceutical and life sciences space. You will implement and support Veeva Vault RIM, collaborate with regulatory affairs, quality, and IT, and drive submission tracking while ensuring FDA/ICH and GxP compliance and data integrity.

The role includes gathering requirements, configuring workflows, testing, validating releases, and preparing specifications,

Qualifications

  • Hands-on Veeva Vault RIM implementation, configuration, or support.
  • Strong understanding of regulatory affairs and RIM processes.
  • Experience with regulatory submissions, product registrations, and submission tracking.
  • Familiarity with GxP, data integrity, change control, and CSV where applicable.
  • Excellent communication and stakeholder management skills.

Responsibilities

  • Implement, configure, maintain, and support Veeva Vault RIM applications.
  • Collaborate with regulatory teams to manage regulatory information and submissions.
  • Support RIM modules such as Registrations, Submissions, Submissions Archive, and Regulatory Operations.
  • Gather requirements, perform gap analyses, and translate needs into solutions.
  • Configure workflows, metadata, reports, dashboards, and user permissions.
  • Track submission milestones and maintain submission records.
  • Coordinate with regulatory affairs, quality, IT, analysts, developers, and validation teams.
  • Perform functional, integration, UAT testing; resolve defects and validate releases.
  • Support data migration, cleansing, mapping, and legacy system integration.
  • Ensure compliance with FDA, ICH, and GxP requirements.
  • Prepare functional specs, configuration docs, SOPs, and training materials.
  • Troubleshoot issues and provide ongoing production support.

Skills

Veeva Vault RIM
Regulatory Affairs
Regulatory submissions
GxP & data integrity
Requirements gathering
Business process mapping
Testing & validation
Stakeholder management
Documentation & training

Job description

Stanley David and Associates is seeking an experienced Veeva RIM Consultant to lead regulatory information management initiatives in the pharmaceutical and life sciences space. You will implement and support Veeva Vault RIM, collaborate with regulatory affairs, quality, and IT, and drive submission tracking while ensuring FDA/ICH and GxP compliance and data integrity.

The role includes gathering requirements, configuring workflows, testing, validating releases, and preparing specifications,

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