Associate Director, Regulatory Operations - Veeva Vault RIM

Role Summary:

The Associate Director, Regulatory Operations – Veeva Vault RIM is a key member of the Regulatory Operations team responsible for the business ownership, administration, governance, optimization, and ongoing evolution of Dyne’s Regulatory Information Management capabilities. This role serves as the primary subject matter expert for Veeva Vault RIM and partners with Regulatory Affairs, Quality, Information Technology, Clinical, CMC, Pharmacovigilance, vendors, and other stakeholders to ensure regulatory information, processes, and systems are accurate, compliant, scalable, and inspection ready. 

This role translates regulatory and business needs into practical system solutions, establishes effective data and process governance, leads system enhancements and release readiness, and drives consistent adoption through clear standards, documentation, training, and user support. This individual will balance strategic planning with hands-on execution and will play an important role in building the regulatory infrastructure needed to support Dyne’s growing pipeline, global submissions, health authority interactions, and future commercialization. 

This role is fully remote.

Primary Responsibilities Include:

Veeva Vault RIM Business Ownership & Strategy 

• Serve as the business owner and primary subject matter expert for Dyne’s Veeva Vault RIM platform, including applicable capabilities supporting Registrations, Submissions, Submissions Archive, Publishing, Health Authority Interactions, Regulatory Objectives, commitments, reporting, and system administration 
• Define and maintain a scalable RIM operating model, governance framework, enhancement roadmap, and system standards aligned with regulatory priorities, business needs, data integrity expectations, and the evolving needs of Dyne’s pipeline 
• Partner with Regulatory Affairs leadership, Information Technology, Quality, system administrators, vendors, and business stakeholders to prioritize system capabilities, enhancements, integrations, and continuous improvement opportunities 
• Translate regulatory strategy, operational requirements, and user needs into clear business requirements, functional specifications, user stories, workflows, configuration decisions, and implementation plans 
• Evaluate new Veeva releases, functionality, automation opportunities, and industry capabilities and recommend solutions that improve efficiency, compliance, usability, scalability, and regulatory decision-making 
• Maintain a strong understanding of the Veeva Vault RIM data model, object relationships, workflows, metadata, security, reporting capabilities, and module interdependencies 

Regulatory Operations, Submissions & Health Authority Support 

• Partner with Regulatory Affairs leads and cross-functional teams to translate global regulatory strategies into clear operational plans, milestones, submission activities, and system requirements 
• Support submission planning, content planning, tracking, and execution across development programs and regions, including INDs, CTAs, amendments, annual reports, briefing packages, marketing applications, and other regulatory filings as applicable 
• Establish and maintain fit-for-purpose processes for regulatory submissions, registrations, health authority correspondence, questions, commitments, regulatory objectives, and related records 
• Ensure health authority interactions, questions, responses, decisions, commitments, and key regulatory milestones are accurately captured, linked, maintained, and readily available within the RIM environment 
• Partner with Regulatory Operations colleagues and external vendors to support technically compliant, timely, and high-quality submissions and archival activities 
• Develop and maintain portfolio-level visibility into submission plans, milestones, dependencies, status, risks, and health authority commitments 
• Identify operational risks, process gaps, and system constraints that may affect regulatory deliverables and collaborate with stakeholders to develop practical mitigation plans 
• Support regulatory inspection, audit, and due diligence readiness by ensuring regulatory records and supporting documentation are complete, accurate, traceable, and accessible 

System Configuration, Administration & Lifecycle Management 

• Lead or perform business configuration of Veeva Vault RIM, including users, roles, permissions, metadata, document types, object configurations, workflows, lifecycles, picklists, notifications, reports, and dashboards 
• Establish and maintain role-based access, security, and segregation-of-duties controls in partnership with Information Technology, Quality, and functional owners