Associate Director, Regulatory Operations - Veeva Vault RIM 

Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

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

Manage the intake, assessment, prioritization, documentation, testing, implementation, and communication of system changes, enhancements, and defect resolutions

Lead business readiness for Veeva releases and system upgrades, including impact assessments, release planning, regression testing, user acceptance testing, communications, training, and post-implementation support

Coordinate with technical teams and vendors on integrations, data exchanges, migration activities, system performance, issue resolution, and ongoing platform support

Maintain system inventories, configuration documentation, traceability records, decision logs, issue logs, enhancement backlogs, and release documentation

Apply structured change management practices to support successful implementation and sustained adoption of new system capabilities and processes

Regulatory Data Governance, Quality & Reporting

Establish and maintain regulatory data standards, naming conventions, controlled vocabularies, metadata definitions, stewardship responsibilities, and business rules across the RIM environment

Drive the completeness, consistency, accuracy, timeliness, and traceability of regulatory data and documents across products, applications, registrations, submissions, health authority interactions, objectives , and commitments

Define and monitor data quality controls, exception reports, reconciliations, and remediation activities to identify and address data integrity risks

Partner with Regulatory Affairs, CMC, Quality, Clinical, Pharmacovigilance, Enterprise Data, and Information Technology stakeholders to align regulatory information across systems and processes

Develop, maintain , and continuously improve dashboards, reports, and analytics that provide visibility into submission status, health authority communications, commitments, system adoption, data quality, compliance, cycle times, and operational performance

Translate RIM data into clear insights, trends, risks, and recommendations that support regulatory planning, prioritization, leadership decisions, and continuous improvement

Maintain awareness of evolving regulatory data standards and requirements, including IDMP, xEVMPD , structured data, and other global regulatory information initiatives, and assess implications for Dyne’s processes and systems

Compliance, Validation & Inspection Readiness

Ensure Veeva Vault RIM processes, configurations, documentation, and controls comply with applicable GxP requirements, regulatory expectations, com