---
title: 'Associate Director, Regulatory Operations - Veeva Vault RIM at Dyne Therapeutics'
canonical: 'https://feeny.ai/job/associate-director-regulatory-operations-veeva-vault-rim-dyne-therapeutics-6s40gy5y1631'
type: 'job'
last_seen: '2026-10-12'
---

# Associate Director, Regulatory Operations - Veeva Vault RIM at Dyne Therapeutics

- **Company:** Dyne Therapeutics
- **Location:** Remote
- **Compensation:** $160k–$195k
- **Work type:** remote
- **Posted:** 2026-10-06
- **Last confirmed live:** 2026-10-12
- **Apply:** https://job-boards.greenhouse.io/dynetherapeutics/jobs/6217206004

## Job description

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/](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0), and follow us on [X](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0), [LinkedIn](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0) and [Facebook](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0).

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

#LI-Onsite MA Pay Range $160,000—$195,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

## About Dyne Therapeutics

## Company Overview
- **One-liner**: Dyne Therapeutics is a clinical-stage biotechnology company developing targeted nucleic acid therapies for genetically driven neuromuscular diseases using its proprietary FORCE™ platform.
- **Entity Type**: Public (NASDAQ: DYN)
- **Headquarters**: Waltham, Massachusetts, United States
- **Founded**: 2018
- **Founders**: Not publicly available (the company was co-founded by a team of scientists and entrepreneurs; individual names not surfaced in search results)

## Core Business
- **Primary industry**: Biotechnology / Biopharmaceuticals – rare neuromuscular disease therapeutics
- **Target customers**: B2B / B2G – regulatory agencies, healthcare providers, payers, and most importantly patients with Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), facioscapulohumeral muscular dystrophy (FSHD), and Pompe disease.
- **Mission / Purpose**: “Delivering functional improvement for people living with neuromuscular diseases.” [dyne-tx.com](https://www.dyne-tx.com/)

## Products & Services
Dyne’s pipeline is built around its FORCE™ platform, which uses an antigen-binding fragment (Fab) conjugated to transferrin receptor 1 (TfR1) to deliver therapeutic payloads to muscle and the central nervous system.

- **Z‑rostudirsen (DYNE‑251)** – An investigational therapeutic for DMD patients amenable to exon 51 skipping. Consists of a phosphorodiamidate morpholino oligomer (PMO) conjugated to an anti‑TfR1 Fab. Phase 1/2 DELIVER trial met primary endpoint; BLA submission for U.S. Accelerated Approval planned for Q2 2026 with potential launch in Q1 2027. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)
- **Z‑basivarsen (DYNE‑101)** – Investigational therapeutic for DM1, using an antisense oligonucleotide (ASO) conjugated to anti‑TfR1 Fab. Phase 1/2 ACHIEVE trial fully enrolled; Phase 3 HARMONIA trial ongoing. [dyne-tx.com](https://www.dyne-tx.com/pipeline/)
- **DYNE‑302** – Preclinical candidate for FSHD, using an siRNA payload to suppress DUX4 expression. [dyne-tx.com](https://www.dyne-tx.com/pipeline/)
- **DMD Franchise Expansion** – Four additional development candidates (DYNE‑253, DYNE‑245, DYNE‑244, DYNE‑255) targeting exons 53, 45, 44, and 55 for DMD, entering IND‑enabling studies. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)

## Market Standing
- **Valuation / Market Cap**: Not disclosed in search results (public company; market cap fluctuates with stock price; current figure not provided in the sources).
- **Key Metric**: Cash, cash equivalents and marketable securities of **$1.1 billion** as of December 31, 2025, providing runway into Q1 2028. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)
- **Notable Investors / Partners**: Not listed in provided search results (likely institutional investors; prior venture rounds not detailed here).
- **Growth Signals**:
  - Headcount grew **38.2% YoY** to **227 employees** (2025). [linkedin.com](https://www.linkedin.com/company/dynetx)
  - Positive topline results from DELIVER trial for z‑rostudirsen; potential first product launch in Q1 2027 if approved.
  - Advancing five distinct clinical/preclinical programs across multiple neuromuscular indications.

## Competitive Advantages
- **FORCE™ Platform**: Differentiated delivery technology that uses a TfR1‑binding Fab to enable broad and deep tissue penetration in both muscle and CNS – addressing one of the biggest hurdles in neuromuscular drug development.
- **Best‑in‑Class Potential**: Clinical data for z‑rostudirsen showed statistically significant dystrophin expression (5.46% of normal at 6 months, 7‑fold change) and preservation of lung function (FVC%p) compared to placebo, despite a small trial not powered for functional endpoints.
- **Broad Pipeline**: Covering multiple exon‑skipping opportunities in DMD as well as entirely different diseases (DM1, FSHD, Pompe) with the same core platform, reducing risk and enabling rapid expansion.

## Strategic Focus
- **Regulatory Submission**: File a Biologics License Application (BLA) for z‑rostudirsen in Q2 2026 under U.S. Accelerated Approval pathway.
- **Late‑Stage Trials**: Initiate two field‑defining Phase 3 confirmatory trials (FORZETTO for DMD and HARMONIA for DM1) in 2026 following FDA alignment on design.
- **Pipeline Expansion**: Move four additional DMD exon‑skipping candidates into IND‑enabling studies and advance preclinical DYNE‑302 (FSHD) toward the clinic.
- **Commercial Readiness**: Prepare for potential first‑ever company launch in Q1 2027 with a focus on U.S. market, while also pursuing ex‑U.S. approval pathways.

## Why Work Here
- **Mission‑Driven Culture**: The company’s “One Dyne community” ethos emphasizes accountability, transparency, fearlessness, and a relentless drive to deliver functional improvement for patients and families. [dyne-tx.com](https://www.dyne-tx.com/careers-culture/)
- **Competitive Benefits**: Medical, dental, vision, 401(k), flexible vacation, paid holidays including a year‑end office closure, short‑ & long‑term disability, HSA/FSA accounts. [dyne-tx.com](https://www.dyne-tx.com/careers-culture/)
- **Work Environment**: Office location in Waltham, MA (Boston area). Remote/hybrid policy not specified in search results; likely on‑site or hybrid for lab‑based roles. Career page lists roles such as Associate Director, Oligonucleotide Development; Scientist, RNA; Director of Training – reflecting a mix of research, clinical, and corporate functions. [job-boards.greenhouse.io](https://job-boards.greenhouse.io/dynetherapeutics)
- **Growth Opportunity**: Joining a late‑stage biotech with a validated platform, strong cash position, and a clear path to commercialization – offering employees exposure to both R&D and upcoming launch activities.
- **Recruitment Scam Warning**: Dyne posts an explicit notice on its careers page that it never requests financial details or payment during hiring; all legitimate emails come from @dyne‑tx.com addresses.

## Sources
1. [dyne-tx.com – Company Overview](https://www.dyne-tx.com/)
2. [dyne-tx.com – Careers & Culture](https://www.dyne-tx.com/careers-culture/)
3. [dyne-tx.com – Pipeline](https://www.dyne-tx.com/pipeline/)
4. [investors.dyne-tx.com – Q4/Full Year 2025 Results](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)
5. [linkedin.com – Dyne Therapeutics Company Profile](https://www.linkedin.com/company/dynetx)
6. [job-boards.greenhouse.io – Dyne Careers Page](https://job-boards.greenhouse.io/dynetherapeutics)

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