BeOne Medicines

Compensation

Full Description

Job Description: • 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 • Develop, implement, and monitor Issues, Quality Events, CAPAs, and Deviation processes specific to Regulatory Affairs and Regulatory Operations, ensuring alignment with BeOne standards • 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 • 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 • 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 • Partner cross-functionally with Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC, and other teams to identify compliance gaps and embed sustainable compliance 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 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 Requirements: • 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 Benefits: • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness