Remote Senior Regulatory Documentation Lead

BeOne Medicines Ltd.; Mountain Home (TX); Remote; USD 82,000 - 112,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee appendices documents within Veeva Vault, coordinating submissions to regulatory authorities for clinical study reports.

The role can be performed remotely or from BeOne’s global offices, with emphasis on timely, accurate documentation in line with ICH and FDA requirements. You will work with the Global Medical Writing team to assemble binders, manage timelines, perform quality checks, and guidance on SOP updates.

Qualifications

• Masters degree or BA/BS plus 2+ years in pharma or biotech
• Experience with document management and regulatory submissions
• Strong English written and verbal communication
• Remote work or BeOne office-based work flexibility

Responsibilities

• Coordinate and collect appendices for regulatory submissions
• Ensure compliance with FDA/ICH guidelines
• Manage appendices timelines and liaise with Medical Writers and cross-functional teams
• Quality check and approve appendices documents
• Assist Medical Writers with SOP or WI updates in DS scope

Skills

English communication

Project management

Prioritization

Regulatory knowledge

Cross-functional collaboration

Problem-solving

Education

Masters degree or BA/BS + 2+ years pharma/biotech

BA/BS + masters/PharmD/ PhD a plus

Tools

Veeva Vault

Microsoft Office

SharePoint

Job description

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee appendices documents within Veeva Vault, coordinating submissions to regulatory authorities for clinical study reports.

The role can be performed remotely or from BeOne’s global offices, with emphasis on timely, accurate documentation in line with ICH and FDA requirements. You will work with the Global Medical Writing team to assemble binders, manage timelines, perform quality checks, and guidance on SOP updates.