RIO Execution Hub (EH) Manager

Job description

JOB SUMMARY The EH Manager, Sr. Manager is responsible for providing operational regulatory support for designated countries, clusters and/or regions. This role supports submission logistics and technical aspects, ensuring development and delivery of X-regional, regional and/or national regulatory dossiers from initial application and subsequent lifecycle updates, guaranteeing regulatory compliance throughout the submission process. It is expected that this role partners closely with the Country Regulatory Strategist (CRS), International Labeling & Artwork (ILA) and other relevant stakeholders as required, to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to: Planning regulatory submission timelines ensuring regulatory systems are up to date. M1 dossier components (authoring, delivery and/or coordination of local, submission-ready documents), excluding labeling and artwork components. Simple local only HA query responses authoring. Promptly escalate any submission plan delays and develop mitigation strategies aligned with the assessed impact and associated risks The quality review/approval of the Dossier structure for applicable submissions, when required. Provide support for general x-functional activities to country Regulatory teams for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning. Identify opportunities to streamline the end-to-end regulatory process, applying digital tools when applicable. Given the global span of the organization, critical features of this role require strong project management, regulatory operations expertise & digital skills, and the ability to collaborate effectively across diverse cultures, functions, and geographic regions. The individual serves as a trusted partner to global, regional, cluster and local stakeholders, ensuring the timely delivery of high-quality regulatory submissions and operational regulatory support that enables patient access and business objectives. JOB RESPONSIBILITIES General responsibilities: Leads and coordinates from moderate to complex regulatory submissions (Growth & complex lifecycle) for assigned products aligned with business priorities and needs. Accountable for delivering designated tasks with quality and timely as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement. Authors, reviews, and maintains local regulatory documents (Module 1 dossier components) for the submission categories / markets or products assigned. Manages and coordinates components receipt, translation management, dossier compilation, local ancillary legalization, and submission readiness to facilitate timely Health Authority submissions. Tracks and develops action plans to maintain or improve operational performance against portfolio management, data health, KPI, quality metric, and audit requirement targets for the markets/clusters under responsibility. Ensures the timely delivery of high-quality regulatory submissions and dossier components, monitoring them against milestones to meet business-critical timelines and regulatory requirements. Manages the authoring of simple HA query responses e.g., admin related requests, and coordinates with relevant SMEs/functions to address more complex HA queries, based on CRS query response strategy. Coordinates support to tenders, out-of-stock reporting, Annual Product Quality Reviews, local audit readiness, risk minimization activities, Dear Healthcare Professional Communications (DHPCs), responses to medical information requests and other regulatory operational activities. Partners with cross-functional stakeholders and third-party partners to ensure successful delivery of regulatory priorities and operational plans. Escalates and communicates issues that may impact submission timelines, quality, compliance, or business commitments, including the timely identification, escalation of Quality Events affecting their processes, deliverables, or areas of responsibility. Maintains required training curricula and demonstrates continued proficiency in regulatory processes, submission requirements, tools, and systems. Actively identifies, evaluates, and implements opportunities to improve submission processes, regulatory operations workflows, and dossier execution efficiencies at the local, regional, and global levels. Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor. Lead or contribute to projects impacting people, processes, technology, and operational excellence across RIO and GRS. Partner with global colleagues and key stakeholders to support critical, high-priority, and accelerated submissions, ensuring successful execution against regulatory and business objectives. Leads project management activities for regulatory submissions, including development of timelines, work plans, deliverables, risk assessments, and mitigation strategies. Monitors’ submission progress and proactively identify, escalate, and resolve issues impacting quality, compliance, resource requirements, or regulatory timelines and support of CAPAs for Quality Events affecting their processes, deliverables, or areas of responsibility. Represents regulatory operations in project meetings, advocating realistic deliverables, communicating risks, and providing status updates on submission activities. Contributes to forecasting and resource planning activities, supporting flexible resourcing and global workload sharing to optimize delivery of regulatory commitments. Drives adoption of standardized document authoring, publishing, document management, and archival processes to improve quality, compliance, and operational effectiveness. Applies advanced regulatory and operational knowledge to deliver business outcomes across complex projects and regulatory initiatives. Demonstrates critical thinking and sound judgment when balancing quality, compliance, risk, and speed in a dynamic regulatory environment. Supports the development of digital and automation solutions that simplify regulatory processes, improve operational efficiency, optimize resource utilization, and support continuous improvement across regulatory operations. Leads discussions for complex regulatory projects and ensure alignment of submission strategies across global, regional, and local stakeholders. Cultivates a culture of continuous learning, digital fluency, innovation, collaboration, and operational excellence through the adoption or leadership for development of digital solutions, proactive problem-solving, and strong stakeholder engagement. Manager: Business Experience (Portfolio): Experience in leadership of moderately complex portfolio activity and application of technical experience to impact business results. Portfolio activity relates to: Input to the planning and leadership in the monitoring and compilation of visible and timebound major applications (E.g. New Registrations, Line Extensions, Global Clinical Trials). Lifecycle portfolio planning with challenging internal (e.g. countries with shared packs) or external constraints (e.g. BoH capacity/regulations). Publishing Expert with extensive technical/ regional expertise; assumes role as Project Manager leading Complex/Major submissions with matrix oversight of global publishing team (vendors/FTEs). Workstream leads/Lead SME in support of sub functional ACD activities or leadership of small/less complex ACD activity. Business Experience (Non-portfolio): Experience in providing SME input to non-portfolio Continuous Improvement projects which impact people, technology and/or processes within GRS. Experience in providing SME input for function played within GRS transformation projects. Considered a technical resource within the group. Repr