Manager, Regulatory Compliance Programs

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.

General Description: 
The Manager, Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving program-level compliance initiatives, monitoring regulatory operations, and ensuring alignment with global health authority expectations. 

This role provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC, and Regulatory Technology teams. While Regulatory Operations manages the execution of health authority queries (HAQs), regulatory commitments, and regulatory data in BRIM, the Manager, Regulatory Compliance Programs ensures these activities are performed in a compliant, consistent, and audit-ready manner. Additionally, the role supports inspection readiness, regulatory intelligence, audits, compliance analytics, and continuous improvement initiatives, helping to strengthen BeOne’s global regulatory compliance framework and ensuring proactive identification and mitigation of compliance risks. 
 

Regulatory Compliance Framework & Readiness 

• Support the implementation and strengthening of BeOne’s Global Regulatory Compliance Framework. 

• Ensure regulatory programs are aligned with global health authority expectations. 

• Contribute to inspection readiness planning and execution, including pre-inspection assessments, mock inspections, and post-inspection follow-up. 
   

Regulatory Compliance Programs & Health Authority Interactions 

• Support regional regulatory offices to ensure compliance programs align with global standards. 

• Assist in implementation of regional compliance initiatives, inspection readiness programs, and training. 

• Serve as a point of contact for regional compliance questions, gaps, and escalations. 

• Provide compliance oversight and guidance for the management of health authority queries (HAQs), regulatory commitments, and follow-up actions handled by Regulatory Operations. 

• Review and monitor HAQ and commitment tracking to ensure alignment with BeOne’s standards, GxP requirements, and global regulatory expectations. 

• Identify trends, systemic gaps, or potential compliance risks in HAQ management and recommend corrective actions. 

• Serve as a point of contact for compliance-related questions regarding HAQs and commitments and support cross-functional escalation as needed. 

• Maintain a repository of global regulatory guidance, alerts, and inspection outcomes to inform programs. 

• Support implementation of compliance initiatives across regulatory operations. 

• Collaborate with Reg Ops to ensure that all regulatory communications are audit-ready, documented, and compliant. 
   

Regulatory Intelligence & Risk Management 

• Track global regulatory trends, enforcement actions, and inspection outcomes. 

• Assess potential impact of regulatory changes on products, processes, and operations. 

• Provide proactive recommendations to mitigate compliance risks and support leadership decision-making. 

Audit