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, company policies, data integrity principles, and validated-system procedures 
• Partner with Quality and Information Technology to define and execute a risk-based computer system validation and change-control approach for new capabilities, configurations, integrations, upgrades, and enhancements 
• Lead or support validation deliverables, including requirements, risk assessments, test plans, test scripts, traceability, deviations, summary reports, and approval documentation 
• Maintain oversight of audit trails, periodic reviews, access reviews, system issues, deviations, corrective and preventive actions, and other compliance-related activities 
• Serve as the Regulatory Operations system representative during audits, inspections, due diligence activities, and internal compliance reviews 
• Proactively identify compliance and inspection-readiness risks and lead remediation plans in partnership with appropriate stakeholders 
• Ensure system and process documentation remains current, approved, controlled, and aligned with actual business practices 

Process Excellence, Documentation & User Enablement 

• Lead the design, harmonization, documentation, and continuous improvement of regulatory operations processes across programs, functions, and regions 
• Develop and maintain policies, standard operating procedures, work instructions, process maps, job aids, templates, governance documents, and system administration guides 
• Apply a user-centered and risk-based approach to simplify workflows, reduce manual effort, improve cycle times, increase data quality, and strengthen operational consistency 
• Develop and execute role-based training, onboarding, refresher training, office hours, and communication plans that build user capability and drive consistent adoption 
• Establish a sustainable support model for user questions, access requests, issue triage, escalation, resolution, and knowledge management 
• Gather and analyze user feedback, system usage, support trends, and performance data to identify opportunities to improve the user experience and business outcomes 
• Promote effective use of Veeva Vault RIM and reinforce accountability for regulatory data ownership, process adherence, and documentation quality 

Cross-Functional Leadership & Vendor Management 

• Serve as a trusted partner to Regulatory Affairs, Regulatory Operations, CMC, Quality, Clinical Development, Clinical Operations, Pharmacovigilance, Medical Writing, Information Technology, Program Management, and other stakeholders 
• Lead cross-functional workstreams and projects involving regulatory systems, data, processes, integrations, submissions, and operational readiness 
• Facilitate requirements workshops, design discussions, governance forums, status reviews, decision-making sessions, and issue-resolution meetings 
• Communicate system strategy, priorities, progress, risks, dependencies, tradeoffs, and recommendations clearly to functional leaders, project teams, and senior stakeholders 
• Manage vendor and consultant activities, including scope, timelines, deliverables, quality, issue resolution, knowledge transfer, and performance oversight 
• Influence outcomes without direct authority and build alignment across technical and nontechnical stakeholders with differing priorities 
• Provide guidance, coaching, and subject matter expertise to system administrators, contractors, regulatory colleagues, and end users 
• Model Dyne’s values and foster a culture of accountability, collaboration, integrity, quality, urgency, and continuous improvement 

Education and Skills Requirements:

• 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, Regulatory Information Management, regulatory systems, regulatory data management, or a related discipline within the pharmaceutical or biotechnology industry 
• 5+ years of direct, hands-on experience with Veeva Vault RIM in a business owner, functional lead, product owner, system administrator, business analyst, or comparable role 
• Deep working knowledge of Veeva Vault RIM capabilities, including Registrations, Submissions, Submissions Archive, Publishing, Health Authority Interactions, Regulatory Objectives, commitments, reporting, workflows, metadata, lifecycles, user access, and object security 
• Demonstrated experience translating regulatory and business requirements into scalable system configurations, workflows, data standards, reports, and operational solutions 
• Strong understanding of global regulatory operations, drug development processes, regulatory submission pathways, regulatory content management, registration management, health authority interactions, and product lifecycle activities 
• Experience supporting global regulatory submissions and associated planning, tracking, document management, publishing, archival, and compliance activities 
• Demonstrated knowledge of GxP requirements, computer system validation, 21 CFR Part 11, data integrity principles, audit trails, electronic records, change control, and inspection-readiness expectations 
• Experience leading Veeva releases, system enhancements, user acceptance testing, validation activities, data migration, system implementation, or integration initiatives 
• Experience establishing or improving regulatory data governance, metadata standards, controlled vocabularies, data-quality controls, stewardship models, and reporting practices 
• Familiarity with regulatory data standards and initiatives such as IDMP, xEVMPD, structured content planning, and structured regulatory data preferred 
• Experience developing dashboards, metrics, reports, and operational insights using Veeva reporting capabilities, Microsoft Excel, Power BI, Tableau, or similar tools preferred 
• Demonstrated ability to develop clear policies, standard operating procedures, work instructions, process maps, business requirements, functional specifications, test scripts, training materials, and system documentation 
• Strong project and program management skills, with the ability to plan and lead complex cross-functional initiatives, manage dependencies, identify risks, resolve issues, and deliver high-quality outcomes against firm timelines 
• Proven ability to lead through influence, build alignment, and collaborate effectively across Regulatory Affairs, Quality, Information Technology, Clinical, CMC, Pharmacovigilance, vendors, and other functional partners 
• Strong analytical, critical-thinking, and problem-solving skills, with the ability to evaluate complex processes and data and translate findings into practical recommendations 
• Excellent written, verbal, facilitation, and presentation skills, with the ability to communicate technical and regulatory concepts clearly to diverse audiences 
• Strong attention to detail and demonstrated commitment to data integrity, compliance, documentation quality, operational excellence, and inspection readiness 
• Ability to balance strategic planning with hands-on execution and operate with independence, sound judgment, accountability, urgency, and flexibility in a growing biotechnology company 
• Demonstrated ability to manage multiple priorities and adapt effectively in a fast-paced, matrixed environment with evolving business and regulatory needs 
• Veeva Vault Administrator certification or other relevant Veeva certification strongly preferred 
• Experience in rare disease, neuromuscular disease, genetic medicine, oligonucleotide therapeutics, or a clinical-stage biotechnology environment preferred 
• Experience managing vendors, consultants, contractors, or external service providers preferred 
• Ability to travel as needed for internal meetings, vendor engagements, training, audits, or other business activities
   

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