Remote Senior Regulatory Document Specialist

BeiGene, Ltd.; United States; Remote; USD 82,000 - 112,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Paid Time Off & Wellness

Job summary

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee appendices for regulatory submissions, ensuring ICH/FDA compliance and on-time delivery. The role may be done remotely or from BeOne offices worldwide, leveraging Veeva Vault.

You will coordinate with Medical Writing, manage timelines, perform quality checks, and support DS scope updates. Requires strong English, regulatory knowledge, and project management skills. Competitive salary and benefits.

Qualifications

• Masters degree or BA/BS plus 2+ years in pharma/biotech document management.
• Experience with regulatory submissions (FDA, ICH) preferred.
• Strong written and verbal English communication.
• Ability to manage multiple documents and timelines under deadlines.

Responsibilities

• Oversee appendices collection and coordination for regulatory submissions.
• Ensure compliance with FDA/ICH guidelines and internal standards.
• Coordinate with Medical Writers and cross-functional teams on timelines.
• Work in Veeva Vault to manage workflows and approvals.
• QC and approve appendices documents; support DS updates.

Skills

English communication

Prioritization

Regulatory knowledge

Project management

Teamwork

Independent problem solving

Education

Masters degree

BA/BS + 2+ years experience

PhD/PharmD a plus

Tools

Microsoft Word

Microsoft Outlook

Excel

PowerPoint

Adobe Acrobat

Veeva Vault

SharePoint

Job description

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee appendices for regulatory submissions, ensuring ICH/FDA compliance and on-time delivery. The role may be done remotely or from BeOne offices worldwide, leveraging Veeva Vault.

You will coordinate with Medical Writing, manage timelines, perform quality checks, and support DS scope updates. Requires strong English, regulatory knowledge, and project management skills. Competitive salary and benefits.