Global Regulatory Compliance & Inspection Lead

BeiGene, Ltd.; United States; Remote; USD 140,000 - 185,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Paid Time Off

Wellness Program

Job summary

BeOne seeks a Senior Manager, Global Regulatory Compliance & Inspection Readiness to lead regulatory compliance programs, risk assessments, and inspection readiness across the GRA function. You will partner with Quality, PV, Clinical, Regulatory Operations, and IT to ensure compliant processes and robust information management.

The role emphasizes data stewardship in Veeva RIM and cross-functional remediation oversight.

Qualifications

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• 7+ years of experience in Regulatory Affairs/Compliance in pharma/biotech.
• Strong knowledge of FDA, EMA, ICH, and GxP requirements.
• Experience leading audits/inspections and remediation.
• Experience with Veeva Vault RIM or similar systems.

Responsibilities

• Lead regulatory compliance risk assessments and mitigation actions across GRA.
• Prepare for audits and health authority inspections with SMEs and coaching.
• Monitor regulatory information, data management, and RIM oversight.
• Develop and track KPIs, dashboards, and escalation thresholds.
• Drive continuous improvement and compliance culture across teams.
• Manage and mentor team members and contractors.

Skills

Regulatory affairs

Regulatory compliance

Quality

GxP

Leadership

Data analysis

Veeva RIM

Education

Bachelor's degree in Life Sciences/Regulatory Affairs/Quality/Technology

Tools

Veeva Vault RIM

Job description

BeOne seeks a Senior Manager, Global Regulatory Compliance & Inspection Readiness to lead regulatory compliance programs, risk assessments, and inspection readiness across the GRA function. You will partner with Quality, PV, Clinical, Regulatory Operations, and IT to ensure compliant processes and robust information management.

The role emphasizes data stewardship in Veeva RIM and cross-functional remediation oversight.