Senior Manager/Manager, Regulatory Operations

Corbus Pharmaceuticals Inc•Norwood, MA

12d•Hybrid

About The Position

This Regulatory Operations role will be responsible for the operational execution of U.S. regulatory submissions and for establishing reliable, well-organized document management practices within Regulatory Affairs. This individual will oversee the use of Veeva Vault for Regulatory, ensuring proper document handling, consistent application of workflows, and well-maintained submission documentation. The role centers on Veeva oversight, submission content preparation, formatting, publishing, and coordination across functional teams to support timely and compliant regulatory filings. This person 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 also 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. This role will be hybrid to the Norwood, Ma office.

Requirements

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-on experience preparing, formatting, compiling, and publishing regulatory submissions in eCTD format for the U.S. (INDs, amendments, reports, meeting packages, general correspondence), including leading the full operational execution of a complete NDA or BLA.
Strong understanding of document formatting standards, submission components, and lifecycle management within an eCTD environment.
Demonstrated ability to coordinate timelines, track deliverables, and manage document readiness across multiple contributors.
Excellent organizational skills with the ability to build and maintain orderly, transparent records of submissions, agency interactions, and regulatory documentation.
Strong communication and collaboration skills, with experience working across functional teams in a fast-paced environment.
High attention to detail and commitment to accuracy and compliance.

Responsibilities

Veeva Vault Oversight and Optimization:
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.
Submission Content Preparation and Execution:
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.
Regulatory Information Organization:
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.
Regulatory Project Coordination:
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.
Operational Excellence and Process Improvement:
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.