• Act as the lead Regulatory Affairs associate on an enterprise-wide strategic initiative to optimize the business’s supply chain • Support global regulatory strategies for changes related to the initiative • Conduct global regulatory change assessments and coordinate associated activities for assigned products • Provide regulatory review of technical reports and documents • Support risk management activities, vigilance reporting activities, and other quality related initiatives • Lead regulatory filings as needed for EU/USA, Canada and support ROW

• Design, manage, and report E2E labeling metrics and KPIs; identify trends, risks, and improvement opportunities • Maintain the Global Labeling Monitoring & Evaluation Plan and develop new metrics for E2E process health • Build dashboards and analytics using Power BI, Excel, and pivot tables • Lead cross-functional alignment on metric definitions, oversight expectations, and reporting cadence • Prepare slide decks for Compliance Councils and governance forums and track follow-up actions to closure • Support Global Labeling Compliance E2E Compliance Meetings, PSMF inputs, PCC, and other compliance governance activities • Manage Pharmacovigilance aggregate report scheduling until transition is complete • Provide analytics-based insights to strengthen regulatory and compliance decision-making • Monitor, validate, and analyze data relevant to labeling implementation and oversight • Prepare audit/inspection evidence and escalate data integrity issues as needed • Support digital enablement initiatives, including data model improvements and process automation • Uphold standards for data quality, integrity, and traceability • Support process updates (e.g., Veeva-related changes) and evaluate downstream process impact • Align with Veeva COP workflows, system handoffs, and system-to-process dependencies • Cross-trained on key process management and Global Labeling training tasks for operational continuity and to provide backup coverage • Contribute to data-driven and compliance reporting projects (e.g., GRA Data Cockpit, data integrity initiatives) • Provide analytic insights to upstream and downstream partners across functions • Prepare and review data-driven audit materials, ensuring accuracy and data integrity • Support maintenance of an audit-ready state and continuous improvement of audit processes

• Lead investigations and CAPA management for labeling-related deviations, driving root-cause analysis, trend identification, and cross-functional remediation • Oversee E2E labeling process updates, escalation management, and process-to-system alignment • Serve as CAPA Owner for process improvements and ensure clear communication of changes to stakeholders • Support business partners and Safety Data Exchange Agreement obligations, ensuring roles, responsibilities, and clear process management are established to comply with contractual terms and conditions • Act as Business Contact for Veeva RIMS, TrackWise, QDocs, and related systems • Oversee system enhancements, issue resolution, and workflow maintenance • Ensure effective process-to-system handoffs to support compliant and efficient labeling operations • Lead preparation and coordination for audits and inspections, ensuring a 'permanently inspection-ready' environment • Maintain the Global Labeling Audit & Inspection Storyboard and develop supporting process flow maps • Produce required system outputs and documentation, and support key SMEs and stakeholders during inspection interviews • Serve as Veeva COP (Community of Practice) process expert and drive continuous improvement initiatives • Ensure consistency of E2E labeling process handoffs across functions and regions • Partner with Regulatory, Pharmacovigilance, Quality, and Manufacturing to address systemic issues and strengthen interdependencies • Develop and deliver Global Labeling training materials • Contribute Global Labeling perspective to regulatory intelligence reviews and process impact assessments

• Monitor and analyze policy, legislative and regulatory developments across the region as relevant to our business. • Keep track of geopolitical and geoeconomic developments and their possible implications for the company. • Leverage reports and analysis from government sources and NAM institutions, to provide inputs on potential policy and regulatory changes that can impact our businesses. • Design and maintain a centralized, structured, searchable knowledge database of key policy documents, regulatory filings, and legislative timelines. • Develop dashboards or trackers to visualize policy trends and regulatory risks. • Produce high-quality policy briefs, impact assessments, and strategic recommendations to support the Communications and Government Relations function. • Early engagement with relevant stakeholders on how potential policy and regulatory changes can impact Hitachi Energy businesses. • Focus on monitoring and leveraging stimulus incentives and funding support at a regional, national, and local level across the region through various channels. • Provide policy insights to support market and technology positioning, product development, and investment decisions. • Support the preparation of briefings and inputs for engagement with policymakers, regulators, and industry associations. • Support the drafting of consultation responses, position papers, and talking points for senior leadership engagement with key stakeholders. • Collaborate internally with key businesses and functions across the company as relevant. • Represent the company in working groups and forums as well as institutional and industry coalitions as required.