Remote Regulatory Submissions & Publishing Manager

Biopharma Careers; United States; Remote; USD 135,000 - 163,000; Full time

Benefits offered by this job

Flexible Time Off (FTO)

11 paid company holidays

160 hours paid vacation annually (non‑

Paid sick leave

Job summary

RayzeBio, a wholly‑owned subsidiary of Bristol Myers Squibb, seeks a Manager, Regulatory Operations and Publishing to lead submission operations, format complex documents, and ensure compliant eCTD submissions. You will coordinate with Regulatory, Clinical, Quality, and vendors to drive timely delivery and maintain reference management in EndNote.

You will also develop and improve SOPs, templates, and publishing standards, while staying current with FDA/ICH guidance for electronic submissions

Qualifications

• Bachelor’s degree with 4+ years of Regulatory Operations experience.
• Experience with Accenture StartingPoint Templates and Veeva RIM preferred.

Responsibilities

• Manage day-to-day regulatory submission operations activities to ensure high-quality, timely, and compliant health authority submissions.
• Format complex documents according to company formatting standards to optimize PDF rendering and limit manual publishing of PDF documents.
• Generate submission-ready PDFs in compliance with regulatory guidance, eCTD requirements, and internal PDF publishing standards.
• Perform technical QC of submission documents and published submissions to ensure accuracy, consistency, completeness, and compliance with submission requirements.
• Manage submission execution activities, including deliverable tracking, timeline coordination, submission readiness assessments, and communication with Regulatory Affairs and cross-functional stakeholders to ensure timely submission delivery.
• Coordinate with external submission vendors to support timely and high-quality submission delivery.
• Provide technical support to authoring teams on the use of StartingPoint templates.
• Support reference management activities, including maintaining references in EndNote or other reference management tools.
• Partner with Regulatory Affairs, Clinical, Nonclinical, CMC, Medical Writing, Quality, and external vendors to resolve formatting, publishing, and QC issues.
• Support creation and maintenance of data, records, and documents in Veeva Vault RIM and other systems, as applicable.
• Support development and continuous improvement of Regulatory Operations SOPs, work instructions, templates, checklists, and submission standards.
• Maintain current knowledge of FDA, ICH, and other applicable regulatory requirements related to electronic submissions and document standards.

Skills

Word formatting

PDF publishing

eCTD knowledge

Submission document QC

Cross-functional collaboration

Organizational skills

Attention to detail

Independent work

Communication skills

Veeva RIM knowledge

Education

Bachelor’s degree

Regulatory Operations experience 4+ years

Tools

StartingPoint Templates

Veeva RIM

EndNote

Job description

RayzeBio, a wholly‑owned subsidiary of Bristol Myers Squibb, seeks a Manager, Regulatory Operations and Publishing to lead submission operations, format complex documents, and ensure compliant eCTD submissions. You will coordinate with Regulatory, Clinical, Quality, and vendors to drive timely delivery and maintain reference management in EndNote.

You will also develop and improve SOPs, templates, and publishing standards, while staying current with FDA/ICH guidance for electronic submissions