RIO Execution Hub (Asia)

RIO Execution Hub (Asia)

10 oct
|
Pfizer
|
Asia

10 oct

Pfizer

Asia

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 integral, regional, cluster and local stakeholders, ensuring the timely delivery of high-quality regulatory submissi

📌 RIO Execution Hub (Asia)
🏢 Pfizer
📍 Asia

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