"Alerted.org

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 & Inspection Support

+ Lead planning, preparation, and execution of internal audits and mock inspections.

+ Support regulatory inspections and ensure timely resolution of audit findings.

+ Integrate lessons learned from inspections and audits into compliance programs for continuous improvement.

Support for Regulatory Operations &** **Veeva** **RIM System

+ Partner with Regulatory Operations to ensure accurate and compliant management of regulatory data in the BRIM system.

+ Monitor data quality, integrity, and completeness of regulatory records, including submissions, HAQs, commitments, and global regulatory documents.

+ Provide guidance and compliance oversight to ensure Regulatory Operations processes adhere to BeOne standards, GxP requirements, and global regulatory expectations.

+ Assist in designing workflow improvements and system enhancements in BRIM to support efficiency, standardization, and regulatory compliance.

+ Identify trends or gaps in regulatory data management and recommend corrective actions or process improvements.

+ Serve as a point of contact for regulatory compliance questions related to Veeva RIM, providing training or clarifications as needed.

+ Ideate dashboards, KPIs, and metrics to monitor compliance trends, emerging risks, and program effectiveness.

+ Partner with Regulatory Technology and data teams to generate actionable insights for senior leadership.

+ Track regulatory intelligence and emerging trends that could impact compliance programs.

Regulatory Document Lifecycle Management

+ Support management of regulatory documentation, including SOPs, risk assessments, master compliance documents, PSMFs, and RMPs.

+ Ensure documents are reviewed, approved, and maintained in alignment with global regulatory expectations.

+ Partner with document control teams to ensure integrity, accessibility, and audit readiness.

Training & Knowledge Sharing

+ Contribute to development and delivery of compliance training modules aligned with regulatory programs.

+ Facilitate global knowledge sharing and awareness of regulatory requirements, inspection outcomes, and lessons learned.

+ Monitor training effectiveness and implement improvements to strengthen compliance culture.

Continuous Improvement & Process Optimization

+ Identify opportunities for process improvement, standardization, and efficiency in compliance programs.

+ Implement lessons learned from audits, inspections, and regulatory intelligence into continuous improvement initiatives.

+ Partner with cross-functional teams to streamline processes, reduce risk, and enhance program effectiveness

Supervisory Responsibilities:

+ May manage direct reports or contractors depending on business needs.

+ Provides mentorship, coaching, and guidance to team members supporting compliance programs.

+ Collaborates closely with cross-functional peers to ensure successful execution of regulatory compliance initiatives.

Computer Skills:

+ Proficiency with regulatory information management systems (e.g., Veeva RIM) and electronic document management systems.

+ Experience with compliance monitoring dashboards, data analytics, and reporting tools (Power BI, Tableau, or equivalent).

+ Proficiency with Microsoft Office Suite (Word, Excel, Power Point, SharePoint, Outlook, Teams).

Other Qualifications:

+ Bachelor’s degree in Life Sciences, Technology, or related discipline required; advanced degrees preferred.

+ 5+ years of experience in regulatory compliance, regulatory operations, quality, or GxP functions in the pharmaceutical or biotech industry required.

+ Strong knowledge of global regulatory requirements and standards, including FDA, EMA, MHRA, Health Canada, PMDA, 21 CFR Part 11, ICH Guidelines, GxP, and ALCOA+ data integrity principles.

+ Experience managing compliance programs, audits, HAQs, regulatory commitments, and reporting.

+ Demonstrated ability to interpret and apply regulatory requirements to operational processes and programmatic initiatives.

+ Strong project management skills, including planning, coordination, risk assessment, milestone tracking, and cross-functional collaboration.

+ Excellent communication and influencing skills across multiple functions and leadership levels.

+ Demonstrated experience in driving compliance initiatives, process improvements, and cross-functional projects.

+ Proficiency with regulatory information management systems, electronic document management systems, dashboards, and data analytics tools (Power BI, Tableau, or equivalent).

+ Ability to work independently and manage multiple priorities in a fast-paced, global environment.

+ Technology Savvy with proven ability to analyze data and interpret into compliance metrics, dashboards and data analytics.

+ Strong communication skills with the ability to influence cross-functionally

+ Experience leading or supporting process improvements and change management.

+ Strong technical writing skills for regulatory and compliance documentation.

**Travel:** < 15%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.