Senior Manager​/Manager, Regulatory Operations

Senior Manager/Manager, Regulatory Operations

This Regulatory Operations role is responsible for the operational execution of U.S. regulatory submissions and for establishing reliable, well-organized document management practices within Regulatory Affairs. The role oversees Veeva Vault for Regulatory, ensuring proper document handling, consistent application of workflows, and well-maintained submission documentation. The focus is on Veeva oversight, submission content preparation, formatting, publishing, and coordination across functional teams to support timely and compliant regulatory filings.

The candidate will support submission planning through timeline coordination, content tracking, and ensuring documents are complete and ready for publishing using Veeva’s core capabilities. They will maintain clear organization of regulatory information, including submission histories, agency correspondence, and key records needed by internal stakeholders. The ideal candidate is detail-oriented, highly organized, and committed to strengthening the operational backbone of the Regulatory Affairs function while contributing to continuous improvement as the company and pipeline grow.

• Serve as the primary operational lead for Veeva Vault within Regulatory Affairs, ensuring the system is structured, organized, and used effectively to support submission preparation.
• Maintain and refine document workflows, metadata practices, folder structures, and naming conventions to ensure consistency and submission readiness.
• Train and support cross-functional contributors on Veeva processes, promoting high-quality document handling throughout the company.
• Monitor content status and document movement within Veeva to ensure completeness and readiness for submission activities.

• Prepare, format, and compile submission components for U.S. regulatory filings including INDs, amendments, reports, responses, and briefing materials.
• Ensure all submission documents meet technical standards, including formatting, bookmarking, hyperlinks, and eCTD readiness.
• Execute publishing of submissions using Veeva’s available capabilities and coordinate final quality checks before submission.
• Maintain clear tracking of all submission components and ensure timely completion by working closely with functional contributors.

• Maintain accurate, accessible records of submission histories, agency correspondence, and regulatory milestones.
• Ensure regulatory documentation is organized, versioned, and easy to locate for both the Regulatory Affairs team and internal stakeholders.
• Manage a log of agency questions, responses, commitments, and key interactions to ensure complete and consistent documentation.

• Develop and manage timelines for regulatory deliverables across Corbus’s programs (CRB-701, CRB-601, CRB-913).
• Coordinate cross-functional inputs, track progress, and ensure alignment with submission schedules.
• Organize document flow for both major and smaller deliverables such as briefing books, meeting packages, and ad hoc regulatory submissions.
• Delegate and oversee technical QC activities by appropriate reviewers to ensure complete and accurate documentation prior to publishing.

• Implement and maintain best practices for document management, submission readiness, and regulatory workflows.
• Identify opportunities to streamline processes as the pipeline grows and operational needs evolve.
• Support the Regulatory Team in maintaining a well-structured, well-documented regulatory function.

• Bachelor’s degree in life sciences or a related field
• 5–10+ years of experience in Regulatory Operations within the biopharmaceutical industry, with clear responsibility for submission preparation and execution
• Advanced proficiency with Veeva Vault for Regulatory, with the ability to configure and maintain document workflows, metadata practices, user guidance, and overall system organization to ensure the platform fully supports high-quality submission preparation
• Hands-o…