Regulatory Operations Lead — Veeva Vault RIM (Remote)

BioSpace; United States; Remote; USD 160,000 - 195,000; Full time

Job summary

Dyne Therapeutics is seeking an Associate Director, Regulatory Operations – Veeva Vault RIM to own and evolve the RIM platform, collaborate with Regulatory Affairs, Quality, IT, and Clinical teams, and ensure scalable, compliant processes. This fully remote role supports global submissions, health authority interactions, and strategic regulatory initiatives.

The role balances strategic planning with hands‑on execution, driving data governance, system enhancements, and training to enable

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• 8+ years of regulatory operations, regulatory systems, regulatory data management, or related experience.
• 5+ years with Veeva Vault RIM as business owner, product owner, or system administrator.
• Deep knowledge of Veeva Vault RIM capabilities, data model, and governance.

Responsibilities

• Lead the regulatory systems, data, processes, and readiness for submissions and health authority interactions.
• Develop policies, SOPs, and training for regulatory operations and RIM governance.
• Translate regulatory requirements into scalable system configurations and workflows.
• Coordinate with cross‑functional teams and vendors to ensure compliant, timely submissions and archival activities.
• Drive inspection readiness through robust documentation, traceability, and data quality controls.
• Develop dashboards and analytics to provide visibility into submission plans, milestones, and performance.

Skills

Veeva Vault RIM

Regulatory operations

Regulatory submissions

Data governance

Dashboards & reporting

Project management

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

Power BI

Tableau

Excel

Job description

Dyne Therapeutics is seeking an Associate Director, Regulatory Operations – Veeva Vault RIM to own and evolve the RIM platform, collaborate with Regulatory Affairs, Quality, IT, and Clinical teams, and ensure scalable, compliant processes. This fully remote role supports global submissions, health authority interactions, and strategic regulatory initiatives.

The role balances strategic planning with hands‑on execution, driving data governance, system enhancements, and training to enable