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Corbus Pharmaceuticals · 1 day ago

Senior Manager/Manager, Regulatory Operations

Norwood, MA

Full-time

Onsite

Mid, Senior Level

5+ years exp

Corbus Pharmaceuticals is an oncology and obesity company committed to helping people defeat serious illness. The Senior Manager/Manager, Regulatory Operations will oversee U.S. regulatory submissions, document management practices, and coordinate cross-functional teams to ensure timely and compliant regulatory filings.

Pharmaceuticals

Hiring Manager

Tim Fay

Responsibilities

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

Qualification

Veeva VaultRegulatory OperationsECTD formatDocument managementSubmission preparationOrganizational skillsCommunication skillsCollaboration skillsAttention to detail

Required

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