Remote Regulatory Operations & Publishing Lead

Bristol-Myers Squibb Co; United States; Remote; USD 119,000 - 144,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

160 hours paid vacation

Global Shutdown

Stock opportunities

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is seeking a Manager, Regulatory Operations and Publishing to oversee regulatory submission operations, format complex documents to current standards, and ensure timely, compliant health authority filings.

You will coordinate with regulatory affairs, clinical, quality, and external vendors, maintain data in Veeva Vault RIM, StartingPoint templates, and EndNote, and contribute to SOPs and submission standards while staying current with

Qualifications

• Bachelor’s degree and 4+ years in Regulatory Operations.
• Experience with StartingPoint templates and Veeva RIM preferred.
• Strong MS Word, PDF publishing, and eCTD knowledge.
• Detail-oriented with strong organizational skills.

Responsibilities

• Manage day-to-day regulatory submission operations to ensure timely, compliant health authority submissions.
• Format documents per company standards to optimize PDF rendering and minimize manual publishing.
• Perform QC of submission documents for accuracy and compliance.
• Coordinate submission readiness and liaise with cross-functional stakeholders.

Skills

Word formatting

PDF publishing

eCTD knowledge

Quality control

Document standards

Cross-functional collaboration

Attention to detail

Project coordination

Communication skills

Education

Bachelor’s degree

Tools

Veeva Vault RIM

EndNote

StartingPoint templates

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is seeking a Manager, Regulatory Operations and Publishing to oversee regulatory submission operations, format complex documents to current standards, and ensure timely, compliant health authority filings.

You will coordinate with regulatory affairs, clinical, quality, and external vendors, maintain data in Veeva Vault RIM, StartingPoint templates, and EndNote, and contribute to SOPs and submission standards while staying current with