Regulatory Operations Lead, Veeva Vault RIM

Dyne Therapeutics, Inc.; United States; Remote; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Dyne Therapeutics, Inc. is seeking a senior RIM Subject Matter Expert to own and advance the Veeva Vault RIM platform across Registrations, Submissions, Publishing, and Health Authority Interactions.

You will shape the operating model, governance, and roadmap while collaborating with Regulatory Affairs, IT, and Quality to prioritize enhancements. You will translate regulatory strategy into functional specs, drive submission planning, and lead configuration and readiness efforts for releases and

Qualifikationen

• Deep understanding of the Veeva Vault RIM data model, object relationships, workflows, and metadata.
• Experience in regulatory operations, submissions, and health authority support.
• Ability to lead system configuration, administration, and lifecycle management.
• Experience managing regulatory records and ensuring inspection readiness.

Aufgaben

• Serve as the business owner and SME for Dyne's Veeva Vault RIM platform, including capabilities for Registrations, Submissions, Publishing, and Health Authority Interactions.
• Define and maintain a scalable RIM operating model, governance framework, and enhancement roadmap.
• Partner with Regulatory Affairs, IT, Quality, and stakeholders to prioritize system capabilities and improvements.
• Translate regulatory strategy and user needs into functional specs, workflows, and implementation plans.
• Support submission planning, content planning, and execution across development programs and regions.
• Lead business configuration of Veeva Vault RIM, including users, roles, permissions, metadata, and workflows.
• Manage intake, assessment, and testing of system changes, enhancements, and defect resolutions.
• Lead business readiness for Veeva releases and system upgrades, including impact assessments and UAT.

Kenntnisse

RIM domain leadership

Business analysis

Stakeholder collaboration

Requirements gathering

Ausbildung

Degree in life sciences or related field

Tools

Veeva Vault RIM

Jobbeschreibung

Dyne Therapeutics, Inc. is seeking a senior RIM Subject Matter Expert to own and advance the Veeva Vault RIM platform across Registrations, Submissions, Publishing, and Health Authority Interactions.

You will shape the operating model, governance, and roadmap while collaborating with Regulatory Affairs, IT, and Quality to prioritize enhancements. You will translate regulatory strategy into functional specs, drive submission planning, and lead configuration and readiness efforts for releases and