[Hiring] Associate Director, Regulatory Operations @Dyne Therapeutics

Role Description

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 various 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.
  • Define and maintain a scalable RIM operating model, governance framework, enhancement roadmap, and system standards.
  • Partner with various stakeholders to prioritize system capabilities, enhancements, integrations, and continuous improvement opportunities.
  • Translate regulatory strategy, operational requirements, and user needs into clear business requirements.
  • Evaluate new Veeva releases and recommend solutions that improve efficiency and compliance.
  • Maintain a strong understanding of the Veeva Vault RIM data model and its components.
• Regulatory Operations, Submissions & Health Authority Support
  • Partner with Regulatory Affairs leads to translate global regulatory strategies into operational plans.
  • Support submission planning, content planning, tracking, and execution across development programs.
  • Establish and maintain fit-for-purpose processes for regulatory submissions and related records.
  • Ensure health authority interactions and key regulatory milestones are accurately captured.
  • Develop and maintain portfolio-level visibility into submission plans and milestones.
  • Identify operational risks and collaborate with stakeholders to develop mitigation plans.
  • Support regulatory inspection readiness by ensuring regulatory records are complete and accessible.
• System Configuration, Administration & Lifecycle Management
  • Lead or perform business configuration of Veeva Vault RIM.
  • Establish and maintain role-based access and security controls.
  • Manage the intake, assessment, prioritization, and documentation of system changes.
  • Lead business readiness for Veeva releases and system upgrades.
  • Coordinate with technical teams on integrations and ongoing platform support.
  • Maintain system inventories and configuration documentation.
  • Apply structured change management practices for new system capabilities.
• Regulatory Data Governance, Quality & Reporting
  • Establish and maintain regulatory data standards and business rules.
  • Drive the completeness, consistency, accuracy, and traceability of regulatory data.
  • Define and monitor data quality controls and remediation activities.
  • Partner with various stakeholders to align regulatory information across systems.
  • Develop and maintain dashboards and reports for visibility into submission status.
  • Maintain awareness of evolving regulatory data standards and assess implications.
• Compliance, Validation & Inspection Readiness
  • Ensure Veeva Vault RIM processes comply with applicable GxP requirements.
  • Partner with Quality and IT to define and execute a risk-based validation approach.
  • Lead or support validation deliverables and maintain oversight of compliance-related activities.
  • Serve as the Regulatory Operations system representative during audits and inspections.
  • Proactively identify compliance risks and lead remediation plans.
  • Ensure system and process documentation remains current and aligned with practices.
• Process Excellence, Documentation & User Enablement
  • Lead the design and continuous improvement of regulatory operations processes.
  • Develop and maintain policies, standard operating procedures, and governance documents.
  • Apply a user-centered approach to simplify workflows and improve operational consistency.
  • Develop and execute role-based training and communication plans.
  • Establish a sustainable support model for user questions and issue resolution.
  • Gather and analyze user feedback to identify opportunities for improvement.
  • Promote effective use of Veeva Vault RIM and reinforce accountability for data ownership.
• Cross-Functional Leadership & Vendor Management
  • Serve as a trusted partner to various stakeholders across the organization.
  • Lead cross-functional workstreams and projects involving regulatory systems.
  • Facilitate requirements workshops and governance forums.
  • Communicate system strategy and priorities clearly to stakeholders.
  • Manage vendor and consultant activities and performance oversight.
  • Provide guidance and expertise to system administrators and end users.
  • Model Dyne’s values and foster a culture of accountability and collaboration.

Qualifications

• Bachelor’s degree in life sciences, information systems, computer science, regulatory affairs, or a related discipline required; advanced degree preferred.
• 8+ years of relevant experience in Regulatory Operations or related discipline within the pharmaceutical or biotechnology industry.
• 5+ years of direct experience with Veeva Vault RIM in a relevant role.
• Deep working knowledge of Veeva Vault RIM capabilities.
• Demonstrated experience translating regulatory and business requirements into scalable system configurations.
• Strong understanding of global regulatory operations and drug development processes.
• Experience supporting global regulatory submissions and compliance activities.
• Demonstrated knowledge of GxP requirements and inspection-readiness expectations.
• Experience leading Veeva releases and system enhancements.
• Experience establishing or improving regulatory data governance and reporting practices.
• Familiarity with regulatory data standards and initiatives preferred.
• Experience developing dashboards and operational insights using reporting tools preferred.
• Strong project and program management skills.
• Proven ability to lead through influence and collaborate effectively.
• Strong analytical, critical-thinking, and problem-solving skills.
• Excellent written, verbal, and presentation skills.
• Strong attention to detail and commitment to data integrity.
• Ability to manage multiple priorities in a fast-paced environment.
• Veeva Vault Administrator certification or other relevant Veeva certification preferred.
• Experience in rare disease or clinical-stage biotechnology preferred.
• Ability to travel as needed for business activities.

Benefits

• Competitive salary range: $160,000 — $195,000 USD.
• Comprehensive health benefits.
• Flexible work arrangements.
• Opportunities for professional development.