Remote Regulatory Operations & Publishing Manager

Bristol Myers Squibb; Lawrence Township (NJ); Remote; USD 119,000 - 144,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Job summary

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, is hiring a Manager, Regulatory Operations and Publishing for a remote role in the United States. You will lead day-to-day submission activities, format complex documents, and ensure high-quality, compliant eCTD submissions across teams.

You will support starting point templates, reference management, and cross-functional coordination while upholding rigorous QA standards and regulatory guidance.

Qualifications

• Bachelor’s degree with 4+ years in Regulatory Operations.
• Experience with Accenture StartingPoint Templates and Veeva RIM preferred.
• Strong formatting, publishing, and QA of regulatory documents.

Responsibilities

• Manage day-to-day regulatory submission operations to ensure timely, compliant health authority submissions.
• Format complex documents per company standards to optimize PDF rendering and minimize manual publishing.
• Generate submission-ready PDFs in line with regulatory guidance and eCTD requirements.
• Perform technical QC of submission documents for accuracy, consistency, and compliance.
• Coordinate submission execution activities, tracking deliverables and timelines, and liaising with cross-functional teams and vendors.
• Provide support to authors on StartingPoint templates and reference management in EndNote or similar tools.
• Collaborate with Regulatory Affairs, Clinical, CMC, and Quality to resolve formatting issues.
• Assist maintenance of data and documents in Veeva Vault RIM and other systems.
• Contribute to SOPs, templates, checklists, and standards for Regulatory Operations.
• Stay current with FDA, ICH, and relevant regulatory requirements for submissions.

Skills

Word formatting

PDF publishing

eCTD submissions

Regulatory submissions

Attention to detail

Project management

Communication skills

Education

Bachelor’s degree in Regulatory Operations

Tools

StartingPoint Templates

Veeva Vault RIM

Job description

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, is hiring a Manager, Regulatory Operations and Publishing for a remote role in the United States. You will lead day-to-day submission activities, format complex documents, and ensure high-quality, compliant eCTD submissions across teams.

You will support starting point templates, reference management, and cross-functional coordination while upholding rigorous QA standards and regulatory guidance.