RIO Execution Hub (EH) Associate, Sr. Associate

The EH Associate, Sr. Associate 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. Responsibilities: 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. Associate: Manages and coordinates lower complexity regulatory activities for assigned products and/or at required dossier execution process workflow as appropriate. 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. Coordinates components receipt, translation management, dossier compilation, local ancillary legalization, and submission readiness to facilitate timely Health Authority submissions. Ensures the timely delivery of high-quality regulatory submissions and dossier components, monitoring them against milestones to meet business-critical timelines and regulatory requirements. Supports authoring of simple HA query responses e.g., admin related requests. Provides 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. Supports continuous improvement initiatives and contributes to projects that enhance regulatory operational excellence, scalability, efficiency, and compliance across the organization. Serves as a subject matter expert for assigned processes, products, regions, or regulatory operational activities, as appropriate. Senior Associate (cumulative from above): Leads and coordinates lower to medium complexity regulatory activities for assigned products and/or at required dossier execution process workflow as appropriate. Coordinates with relevant SMEs/functions to address more complex HA queries, based on CRS query response strategy. 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. <span style="color:#0000