Associate Director, Regulatory Operations - Veeva Vault RIM
Dynetherapeutics · Remote
About this role
**Associate Director, Regulatory Operations – Veeva Vault RIM** **Company Overview** Dyne Therapeutics focuses on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1), along with preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease, and multiple DMD mutations. **Role Summary** The Associate Director, Regulatory Operations – Veeva Vault RIM is a key member of the Regulatory Operations team responsible for 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 across Regulatory Affairs, Quality, IT, Clinical, CMC, Pharmacovigilance, vendors, and other stakeholders to ensure regulatory information, processes, and systems are accurate, compliant, scalable, and inspection ready. This is a **fully remote** role. **Primary Responsibilities** - Serve as the business owner and primary subject matter expert for Dyne’s Veeva Vault RIM platform (including 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 Dyne’s pipeline. - Partner with Regulatory Affairs leadership, IT, 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 business requirements, functional specifications, user stories, workflows, configuration decisions, and implementation plans. *Note: The source text provided appears truncated after the responsibilities list.*
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