[Hiring] Senior Manager, Global Regulatory Process and Compliance @BeiGene

Role Description

The Senior Manager, Global Regulatory Compliance & Inspection Readiness is responsible for leading regulatory compliance programs that strengthen GRA’s compliance health, inspection readiness, regulatory information management, and proactive management of regulatory risk.

• Independently assesses compliance risks and trends.
• Develops risk-based recommendations.
• Leads cross-functional initiatives through implementation and effectiveness monitoring.
• Partners across Global Regulatory Affairs and with Quality, Safety/Pharmacovigilance, Clinical, CMC, Regulatory Operations, and Regulatory Technology.
• Provides oversight of Veeva RIM data stewardship and regulatory information quality.
• Monitors data quality and identifies systemic information and process risks.
• Serves as a key GRA partner for audits and inspections.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, Technology, or related discipline; advanced degree preferred.
• 7+ years of progressive experience in Regulatory Affairs, regulatory compliance, Quality, Regulatory Operations, or another GxP function within the pharmaceutical/biotechnology industry.
• Demonstrated experience independently leading compliance programs, risk assessments, audits/inspection readiness activities, remediation, and cross-functional improvement initiatives.
• Strong working knowledge of FDA, EMA, MHRA, PMDA and other global health authority expectations, ICH guidelines, applicable GxP requirements, 21 CFR Part 11, and ALCOA+ data integrity principles.
• Experience supporting or leading health authority inspections and internal audits.
• Demonstrated ability to perform root-cause analysis, compliance risk assessment, trend analysis, and effectiveness monitoring.
• Experience with Veeva Vault RIM/BRIM or comparable Regulatory Information Management platforms strongly preferred.
• Experience developing compliance KPIs, dashboards, trend analyses, and executive-level reporting.
• Strong analytical and problem-solving capabilities with demonstrated ability to translate data into actionable compliance recommendations.
• Strong project/program leadership, stakeholder management, facilitation, and organizational change capabilities.
• Ability to work independently, manage competing priorities, and exercise sound judgment in a complex global environment.
• RAC, ASQ CQA, Six Sigma/Lean, project management, or comparable certification preferred.

Requirements

• Conduct GRA compliance risk assessments, determine regulatory and business impact, and recommend actions to address identified risks.
• Maintain the GRA compliance risk portfolio, including mitigation actions, owners, timelines, escalation, and effectiveness checks.
• Assess regulatory changes, health authority expectations, audit/inspection outcomes, and internal compliance issues.
• Provide compliance guidance and appropriately challenge practices that create regulatory or inspection-readiness risk.
• Lead GRA preparation for audits and health authority inspections.
• Conduct readiness assessments, identify gaps, and coordinate actions needed before an audit or inspection.
• Prepare GRA SMEs through storyboards, document review, mock interviews, and inspection-readiness coaching.
• Monitor critical GRA processes against defined compliance requirements.
• Establish KPIs, thresholds, and escalation triggers to identify process failures and compliance risks early.
• Investigate recurring issues and adverse trends, determine root cause, and recommend corrective action or process improvement.
• Provide compliance oversight of regulatory information in Veeva RIM.
• Lead Veeva RIM data stewardship activities.
• Develop and monitor GRA compliance KPIs, risk indicators, dashboards, and escalation thresholds.
• Turn audit findings, inspection lessons, compliance assessments, and monitoring results into prioritized improvement actions.
• Work independently to identify, assess, and drive compliance issues to resolution.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and Employee Stock Purchase Plan.
• Participation in the annual bonus plan for Non-Commercial roles and incentive compensation plan for Commercial roles.

Salary Range

$139,800.00 - $184,800.00 annually. Actual compensation packages are determined by several factors unique to each candidate.