RIO Execution Hub Manager

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding what we need to achieve for patients and how we will go about achieving those goals. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Job Summary The RIO Execution Hub Manager is responsible for providing regulatory support to international country and/or cluster regulatory teams. The Hub Manager works across portfolio phases from initial applications, through the commercial lifecycle, to product withdrawal, supporting numerous regulatory activities including M1 dossier components, local-only HA query responses, tenders, out‑of‑stock reporting, annual product quality reviews, risk minimization plans, and coordination of regulatory input for launch planning. The role acts as the initial point of contact for assigned countries/clusters and partners closely with Country Regulatory Strategists, Hub Submission Managers, and other stakeholders to enable timely, high‑quality submissions and sustained compliance. Job Responsibilities The role executes the GRS mission by delivering against goals, initiating and implementing new opportunities, and filling gaps related to the production of regulatory international and operational support. Key aspects include portfolio execution efficiencies, identification and escalation of quality and compliance issues, and management of the cluster/country portfolio with a focus on timeliness, quality, compliance, and efficiency. Ensure timely delivery of local M1 dossier components. Act as the primary point of contact for assigned clusters/countries, coordinating with Country Regulatory Strategists and Hub Submission Managers. Provide regulatory support for functional areas such as tenders, out‑of‑stock reporting, annual product quality reviews, risk minimization plans, and launch‑planning regulatory input. Support local audit readiness activities, including audit interviews and responses to DHPCs and medical information requests. Perform quality review and approval of dossier build Table of Contents provided by Hub Submission/Dossier Managers. Partner with Growth and Regional Submission Hubs to deliver growth applications, meet commercial knot prioritization, and support life‑cycle prioritization discussions for CMC and labelling changes. Local Document Authoring & Submission Prep Author and review M1 local documents (cover letters, variations, MA applications) and relevant translations. Engage with Labeling Hubs and clusters/countries on labels and artwork updates to align with local requirements. Author simple HA query responses and coordinate with SMEs for complex queries. Requirements B.S./B.Sc. in Pharmacy, Life Sciences, Business or Information Technology (or equivalent professional experience). Advanced to fluent English; multilingual skills desirable. Proven technical aptitude and ability to learn new software, regulations, and quality standards quickly. Advanced Microsoft Office Suite skills. Familiarity with pharmaceutical organizational structures, systems, and culture. Understanding of country/cluster regulatory requirements and trends preferred. Relevant experience within pharma, in regulatory, quality, and/or compliance fields. Working Habits Operates independently, is self‑initiated, and navigates ambiguous situations to deliver results. Demonstrates domain expertise that drives execution in complex submission strategies and impacts business outcomes. Shows matrix management experience despite limited autonomy. Pre‑empts internal and external risks, raising and partnering to mitigate them. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. #J-18808-Ljbffr