Associate Director, Regulatory Operations - Veeva Vault RIM

Responsibilities

• Serve as the business owner and primary subject matter expert for Dyne's Veeva Vault RIM platform, including capabilities supporting 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 continuous improvement.
• Translate regulatory strategy and user needs into functional specifications, workflows, and implementation plans.
• Support submission planning, content planning, and execution across development programs and regions.
• Lead or perform business configuration of Veeva Vault RIM, including users, roles, permissions, metadata, and workflows.
• Manage the intake, assessment, and testing of system changes, enhancements, and defect resolutions.
• Lead business readiness for Veeva releases and system upgrades, including impact assessments and user acceptance testing.

Requirements

• 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.

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, targeting muscle and the central nervous system (CNS) to address the root cause of disease.