Remote Regulatory Operations Lead - Veeva Vault RIM

Dyne Therapeutics, Inc.; United States; À distance; USD 160 000 - 195 000; Plein temps

Résumé du poste

Dyne Therapeutics, Inc. is seeking an Associate Director, Regulatory Operations to lead Veeva Vault RIM across submissions, data governance, and lifecycle management.

This fully remote role partners with Regulatory Affairs, Quality, IT, CMC, and Pharmacovigilance to ensure compliant, scalable systems. Responsibilities include defining an operating model, roadmap, release readiness, and enabling efficient health authority interactions while maintaining data integrity and inspection readiness

Qualifications

• Bachelor’s degree in life sciences, information systems, or related field; advanced degree preferred.
• 8+ years in Regulatory Operations or Regulatory Information Management in pharma/biotech.
• 5+ years with Veeva Vault RIM as owner, lead, or administrator.
• Strong data governance, regulatory submission, and inspection-readiness experience.
• Excellent cross-functional collaboration and program-management skills.

Responsabilités

• Own Veeva Vault RIM strategy, governance, and enhancements for regulatory programs.
• Coordinate submissions, health authority interactions, and archival activities.
• Define scalable operating model, roadmap, and release readiness.
• Ensure data integrity, traceability, and compliance across systems.

Connaissances

Regulatory Operations

Veeva Vault RIM

Regulatory submissions

Process governance

Cross-functional collaboration

Documentation & training

Data governance

Inspection readiness

Regulatory strategy

Formation

Bachelor’s degree in life sciences, information systems, or related; advanced degree preferred

Outils

Veeva Vault RIM

Description du poste

Dyne Therapeutics, Inc. is seeking an Associate Director, Regulatory Operations to lead Veeva Vault RIM across submissions, data governance, and lifecycle management.

This fully remote role partners with Regulatory Affairs, Quality, IT, CMC, and Pharmacovigilance to ensure compliant, scalable systems. Responsibilities include defining an operating model, roadmap, release readiness, and enabling efficient health authority interactions while maintaining data integrity and inspection readiness