R&D and Regulatory Systems Manager

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Viatris, a global healthcare company, seeks an R&D and Regulatory Systems Manager to support Regulatory Affairs and R&D functions. This role requires understanding technology needs, ensuring global process and system compliance, and leveraging strong Veeva RIM architecture and development experience. Responsibilities include configuring Veeva RIM Vaults, integrating systems, gathering requirements, leading technical implementations, and ensuring compliance with health authority regulations (FDA, EMA).

The position also involves managing projects, supporting vendor relationships, and driving adherence to IT Quality and SDLC processes. Experience in the pharmaceutical industry, validated GxP environments, and project management methodologies is essential.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number award lists that demonstrate the impact we are making.

This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities.

Every day, we rise to the challenge to make a difference and here’s how the R&D and Regulatory Systems Manager will make an impact:

R&D and Regulatory Systems Manager position works with Regulatory Affairs and other R&D functions to understand technology needs, ensure global processes and systems are compliant and representative of cross functional needs. The successful candidate will demonstrate strong Veeva RIM architecture and development experience including hands on experience of Registrations & Submissions Vault configurations, integrations and data migrations. Business process knowledge is required for requirements elicitation as well as good communication and project management experience to lead technical implementations and take on system ownership.

Key responsibilities for this role include:

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…