R&D & Regulatory Systems Lead (RIM Vault) — Remote

Viatris

United States

Remote

USD 78,000 - 152,000

Full time

3 days ago
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Job summary

Viatris is seeking an experienced R&D and Regulatory Systems Manager to align global R&D processes with regulatory requirements using Veeva RIM Vault. You will lead administration, deployments, and integrations across regions, ensuring compliance with FDA, EMA and other health agencies.

The role requires strong technical and project management skills, hands-on experience with Registrations, Submissions & Archive Vaults, and a proactive approach to drive IT quality and SDLC adherence in a

Qualifications

  • Bachelor's degree in science, IT, or related field.
  • Veeva RIM Vault certification preferred.
  • 7 years of Regulatory business process knowledge with Veeva Vaults.
  • 5 years of software design, system integrations, analytics builds.
  • Experience in pharmaceutical R&D processes and regulated environments.
  • Experience with validated GxP environments and change management.
  • Hands-on Veeva Vault RIM platform experience (Registrations, Submissions & Archive Vaults).
  • Knowledge of GCP, EMA and FDA regulations.
  • Agile, Waterfall, and Hybrid project methodologies.
  • Strong communication and project management skills.

Responsibilities

  • Provide strong knowledge of digital capabilities to support global R&D processes.
  • Monitor global health authority requirements and ensure compliance.
  • Translate business needs into technical requirements and solutions.
  • Gather requirements using functional analysis, user stories, and data flows.
  • Administer and develop Veeva RIM Vault and integrate systems via Vault API.
  • Lead deployment, enhancements, and migrations of RIM Vaults.
  • Design technical solutions and improve system integrations.
  • Manage projects to deliver in scope, schedule, and budget.
  • Collaborate with global teams for end-to-end R&D solution deployments.
  • Ensure compliance with IT Quality and Viatris SDLC processes.
  • Support vendor relationships and escalate system issues as needed.

Skills

Veeva RIM Vault
Java
Python
Power BI
Project management
Requirements elicitation
Regulatory knowledge
Data migrations
System integrations
GxP experience

Education

Bachelor's degree in science/IT
Veeva Vault certification
Advanced degree

Tools

Vault API
GCP

Job description

Viatris is seeking an experienced R&D and Regulatory Systems Manager to align global R&D processes with regulatory requirements using Veeva RIM Vault. You will lead administration, deployments, and integrations across regions, ensuring compliance with FDA, EMA and other health agencies.

The role requires strong technical and project management skills, hands-on experience with Registrations, Submissions & Archive Vaults, and a proactive approach to drive IT quality and SDLC adherence in a

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