Senior Regulatory Operations Lead – Veeva Vault RIM

Dyne Therapeutics, Inc.

Northern (KY)

Remote

USD 160,000 - 195,000

Full time

3 days ago
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Job summary

Dyne Therapeutics, Inc. seeks an Associate Director, Regulatory Operations – Veeva Vault RIM, to lead global regulatory information management and ensure inspection readiness.

You will partner with Regulatory Affairs, Quality, IT, and other stakeholders to translate strategies into practical system solutions, govern data, and drive scalable process improvements for submissions and health authority interactions. This is a fully remote role.

Qualifications

  • Bachelor’s degree in life sciences, information systems, computer science, regulatory affairs, or related discipline.
  • 8+ years in Regulatory Operations, Regulatory Information Management or related regulatory systems.
  • 5+ years hands-on with Veeva Vault RIM in owner/lead role.

Responsibilities

  • Own Veeva Vault RIM platform including registrations, submissions, publishing, and health authority interactions.
  • Define scalable RIM operating model, governance, and enhancement roadmap.
  • Translate regulatory needs into business requirements, specs, and user stories.
  • Evaluate new Veeva releases and automation opportunities for compliance and usability.
  • Lead system upgrades, testing, training, and post-implementation support.
  • Support regulatory submissions planning, tracking, and archival activities.

Skills

Veeva Vault RIM
Regulatory operations
Data governance
Regulatory submissions
Cross-functional collaboration

Education

Bachelor’s degree in life sciences, information systems, computer science, regulatory affairs, or related discipline

Job description

Dyne Therapeutics, Inc. seeks an Associate Director, Regulatory Operations – Veeva Vault RIM, to lead global regulatory information management and ensure inspection readiness.

You will partner with Regulatory Affairs, Quality, IT, and other stakeholders to translate strategies into practical system solutions, govern data, and drive scalable process improvements for submissions and health authority interactions. This is a fully remote role.

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