Senior Manager, Global Regulatory Process and Compliance

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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.

The role independently assesses compliance risks and trends, develops risk-based recommendations, and leads cross-functional initiatives through implementation and effectiveness monitoring. The Senior Manager partners across Global Regulatory Affairs and with Quality, Safety/Pharmacovigilance, Clinical, CMC, Regulatory Operations, and Regulatory Technology to ensure regulatory processes, information, and supporting systems remain compliant, inspection-ready, and aligned with global health authority expectations.

The role provides oversight of Veeva RIM data stewardship and regulatory information quality, partnering with Data Management, Business Process Owners, and Data Owners/Stewards to strengthen data standards, business rules, ownership, and accountability. This includes monitoring data quality and identifying and driving resolution of systemic information and process risks.

The Senior Manager also serves as a key GRA partner for audits and inspections where Regulatory Affairs is host or in scope, leading readiness assessments, SME preparation, audit/inspection support, post-audit assessments, trend analysis, remediation oversight, and integration of lessons learned into the GRA compliance program.

• 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 to determine impacts to GRA.
• Determine whether identified issues require Quality-system action, management escalation, or process improvement and drive the appropriate response.
• Provide compliance guidance and appropriately challenge practices that create regulatory or inspection-readiness risk.

• Lead GRA preparation for audits and health authority inspections where Regulatory Affairs is host or in scope.
• 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.
• Coordinate GRA participation in GCP, GVP, and other GxP audits and inspections with Quality and the audit/inspection host.
• Conduct post-audit and inspection reviews to identify GRA-specific findings, recurring themes, and broader compliance risks.
• Track GRA remediation actions through completion and confirm that actions address the identified risk.

• Monitor critical GRA processes, including health authority questions, regulatory commitments, submissions, and regulatory information, 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.
• Work with Business Process Owners and SMEs to implement actions, assign ownership, track completion, and confirm effectiveness.

• Provide compliance oversight of regulatory information in Veeva RIM to support data quality, completeness, timeliness, traceability, and inspection readiness.
• Lead Veeva RIM data stewardship activities, including monitoring data quality, identifying trends and recurring issues, coordinating remediation, and escalating systemic risks.
• Partner with Data Management, Regulatory Operations, Business Process Owners, and Data Owners/Stewards to establish and maintain data standards, business rules, ownership, and accountability.
• Monitor Veeva RIM data quality metrics and use trends to identify root causes and drive corrective actions or process…