• Prepare and manage marketing authorization (MA) submissions, including the preparation of local administrative documents, quality control (QC), and compilation. • Provide ad hoc regulatory advice on submission packages in the post-authorization stage of the medicinal product lifecycle. • Review and provide linguistic input for local Product Information and Mock-ups. • Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients. • Involvement in project management of the network of local contact persons for Regulatory affairs. • Collect, process, and manage regulatory intelligence to keep the organization informed of key updates and changes. • Propose marketing authorization strategies tailored to client needs. • Act as a deputy for the line manager when required, ensuring seamless continuity in leadership and operations.

• Lead and conduct compliance and workplace investigations across the United States • Gather and analyze evidence, conduct interviews, assess credibility, and make objective findings based on facts and applicable policies • Prepare clear, concise, and fact-based investigation documentation, including interview notes, case summaries, findings, and recommendations • Manage investigations in a timely manner while maintaining consistency, objectivity, confidentiality, and adherence to Compliance and investigative best practices • Present investigation findings, risk assessments, and recommendations to Employment Law, People & Culture, and business leaders • Serve as a trusted advisor to People & Culture Business Partners and business leaders on complex workplace matters • Partner with Compliance colleagues to identify opportunities to enhance investigative processes, controls, policies, training, and risk mitigation efforts

• Support all aspects of the Grievance and Appeals (G&A) compliance program for Medicare, and Medicaid lines of business • Assume the primary role of interfacing with the Compliance department, Auditors, Vendors and G&A staff for purposes of monitoring and ensuring compliant operations • Interface with the Compliance Department and Fraud, Waste and Abuse teams to evaluate and address fraudulent activities impacting the G&A Department • Conduct internal audits, support external audits, develop policies and procedures, and ensure departmental compliance • In partnership with Compliance staff and G&A leadership, develop auditing and monitoring plans to assess compliance with all State, Federal and internal business rules and regulations • Serve as an inter-departmental liaison for compliance and FWA activities • Inform all business operations and workflow decisions to ensure that programs are compliant with State, Federal an internal business rules and regulations • Be fully informed and ensure compliant processes are in place on all G&A business operations • Maintain a current working knowledge of all applicable Medicare, and Medicaid rules and regulations • Conduct frequent monitoring activities of all G&A business operations, publish results and report out to G&A Leadership, Compliance Department, quality committees and other PacificSource leadership teams as applicable • Respond to all compliance related inquiries from internal Compliance Department Staff and external Auditors in a timely, professional and accurate manner

• Support all aspects of the Grievance and Appeals (G&A) compliance program for Medicare and Medicaid lines of business • Assume the primary role of interfacing with the Compliance department, Auditors, Vendors and G&A staff for purposes of monitoring and ensuring compliant operations • Interface with the Compliance Department and Fraud, Waste and Abuse teams to evaluate and address fraudulent activities impacting the G&A Department • Conduct internal audits, support external audits, develop policies and procedures, and ensure departmental compliance • Develop auditing and monitoring plans to assess compliance with all State, Federal and internal business rules and regulations • Serve as an inter-departmental liaison for compliance and FWA activities • Inform all business operations and workflow decisions to ensure that programs are compliant with State, Federal and internal business rules and regulations • Be fully informed and ensure compliant processes are in place on all G&A business operations • Conduct frequent monitoring activities of all G&A business operations, publish results and report out to G&A Leadership, Compliance Department, quality committees and other PacificSource leadership teams as applicable • Respond to all compliance related inquiries from internal Compliance Department Staff and external Auditors