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General Description** **:

The Manager, Regulatory Compliance Readiness will report to the Senior Director of Regulatory Compliance and play a key role in operationalizing BeOne’s Global Regulatory Compliance Framework. This role is responsible for enabling oversight of critical regulatory processes, driving compliance process improvements, and ensuring proactive compliance monitoring. This position combines compliance expertise with data analytics and reporting, leveraging systems such as Veeva RIM to strengthen inspection readiness, deliver actionable compliance insights, and support risk-based decision making. The Manager/Senior Manager will collaborate cross-functionally with BeOne’s internal audit operations, Regulatory Affairs, Quality, Pharmacovigilance, Safety, Clinical, CMC and other teams to implement sustainable compliance controls and practices that are in alignment with global health authority expectations. In addition, partner with the Regulatory Technology team to design and implement Veeva RIM workflows that automate regulatory processes and ensure compliance.

Essential Functions of the** **J** **ob:

Regulatory Compliance Framework & Readiness

+ Support the Global Regulatory Compliance Framework, strengthening inspection readiness and proactive risk oversight across Regulatory Affairs and Regulatory Operations.

+ Contribute to compliance governance, inspection management, and risk assessment activities, including audit/inspection logistics, root cause analysis, and development of risk reports.

+ Act as the first point of contact for reported compliance issues or discrepancies, performing initial assessments and proposing solutions before escalation.

+ Prepare compliance reporting packages and communicate findings, risks, and trends to senior leadership.

Issue, Event, CAPA & Deviation Management

+ Develop, implement, and monitor Issues, Quality Events, CAPAs, and Deviation processes specific to Regulatory Affairs and Regulatory Operations, ensuring alignment with BeOnestandards.

+ Facilitate investigations, author or review investigation reports, and organize cross-functional teams to develop corrective action plans.

+ Review and approve CAPA plans, track progress, escalate hazardous deviations, and provide timely updates to senior management.

+ Generate and issue regular deviation, CAPA, and risk management status reports; develop related training as needed.

Systems, Data Integrity & Workflow Optimization

+ Ideate and support the implementation of electronic workflows within Veeva RIM to automate regulatory processes, partnering closely with the Regulatory Technology team.

+ Ensure data integrity and compliance of regulatory information across systems, with emphasis on Veeva RIM.

+ Provide subject matter expertise on regulatory compliance processes, systems, and data integrity controls.

Risk & Metrics Management

+ Monitor and analyze compliance health metrics, emerging risks, and regulatory trends.

+ Develop and maintain KPIs, trend reports, and dashboards to provide actionable insights to senior leadership.

+ Expedite communication of critical risks and deviations to senior management and recommend mitigations.

Collaboration, Training & Continuous Improvement

+ Partner cross-functionally with Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC, and other teams to identify compliance gaps and embed sustainablecompliance controls.

+ Lead or support process improvement initiatives to enhance efficiency, standardization, and oversight.

+ Write, review, and approve SOPs, Risk Assessments, and related documents.

+ Develop and deliver training on compliance readiness processes.

+ Identify opportunities for streamlining work and improving efficiency, flexibility, and effectiveness.

+ Coordinate and manage multiple compliance activities and projects from initiation to closure.

+ Develop and maintain compliance training curricula specific to Regulatory Affairs and Regulatory Operations, ensuring alignment with global health authority requirements and BeOne standards.

+ Design and deliver targeted training conent on inspection readiness, issue management, deviation/CAPA management and other regulatory compliance processes.

+ Monitor training effectiveness and compliance through assessments, metrics, and feedback, implementing improvements to enhance knowledge retention and regulatory preparedness.

Supervisory Responsibilities:

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

+ Provides mentorship, coaching, and oversight to team members supporting compliance operations.

+ Collaborates closely with cross-functional peers to ensure aligned execution of compliance objectives.

Computer Skills:

+ Strong proficiencywith regulatory information management systems (e.g.Veeva RIM).

+ Strong knowledge of electronic document management systems (EDMS) and workflow automation.

+ Familiarity with quality events, issue management, deviation and CAPA systems.

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

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

Other Qualifications:

+ Bachelor’s degree required with 5+ years of experience in regulatory compliance, regulatory operations, quality, or related GxP functions in the pharmaceutical/biotech industry.

+ Strong knowledge of health authority requirements, inspection trends (FDA, EMA, MHRA, Health Canada, PMDA, 21 CFR Part 11, ICH Guidelines, GxP Regulations), and ALCOA+ data integrity principles strongly desired.

+ Understanding of global regulatory requirements and data standards (e.g. IDMP, xEVMPD, eCTD).

+ Demonstrated experience in compliance risk assessments, inspection readiness, root cause analysis, and regulatory data integrity oversight.

+ 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.

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

+ 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.