Remote R&D & Regulatory Systems Architect

Socket.dev; Wyoming (OH); On-site; USD 78,000 - 152,000; Full time

Job summary

Viatris seeks an R&D and Regulatory Systems Manager to support Regulatory Affairs and R&D functions, ensuring global process compliance and leveraging strong Veeva RIM experience. The role covers configuration, integrations, data migrations, and cross-functional collaboration.

Strong project management, vendor liaison, and SDLC governance are essential. The position requires a Bachelor’s degree in science or IT, 7 years in regulatory processes, and 5 years in software design, with hands-on

Qualifications

• 7 years’ of Regulatory business process knowledge and strong hands-on technical experiences configuring, migrating and integrating Veeva RIM Vaults and other R&D solutions required.
• 5 years’ hands on experience with software design and development, system integrations, analytics report builds required.
• Prior experience in the pharmaceutical industry and a solid understanding of R&D & Regulatory business processes.
• Experience with validated GxP environments, including Implementation, documentation, and change management is necessary.
• Hands on experience implementing, configuring, migrating and integrating Veeva Vault RIM platform including Registrations, Submissions & Archive Vaults (Required). Veeva certification desired.

Responsibilities

• Provide strong working knowledge of the digital capabilities used to support global R&D business processes.
• Monitor emerging global health authority requirements to assess system impact including developing and implementing requirements to ensure compliance.
• Collaborate with key business users to identify business needs and translate to requirements.
• Translate user requirements into technical requirements and implement solutions to meet requirements according to industry best practices.
• Provide analysis techniques including functional requirements gathering, process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis.
• Provide Veeva RIM Vault administration and development expertise including all facets of package software, application implementation and integrate systems using Vault API calls.
• Lead administration, enhancements, fixes, configurations of RIM Vaults and migrate new code fixes in a regular deployment schedule.
• Provide technical design for assigned projects and improve integrations between systems.
• Successfully manage assigned projects to implementation ensuring projects successfully deliver in scope, on schedule and within budget.
• Work with teams globally for end-to-end implementation of various R&D solutions and ensure compliance with regulations by FDA, EMA and other health agencies.
• Drive compliance with IT Quality processes and Viatris SDLC processes, including IT change management and quality/testing procedures.
• Collaborate with solutions lead and business partners to ensure technologies are meeting business requirements.
• Support vendor relationships for assigned R&D systems, ensuring that system issues are promptly escalated.

Skills

Regulatory business process knowledge

Project management

Excellent communication

Attention to detail

Education

Bachelor's degree in science/IT or related field

Tools

Veeva RIM Vault

Java

Python

Power BI

Job description

Viatris seeks an R&D and Regulatory Systems Manager to support Regulatory Affairs and R&D functions, ensuring global process compliance and leveraging strong Veeva RIM experience. The role covers configuration, integrations, data migrations, and cross-functional collaboration.

Strong project management, vendor liaison, and SDLC governance are essential. The position requires a Bachelor’s degree in science or IT, 7 years in regulatory processes, and 5 years in software design, with hands-on