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 Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. The RIO Execution Hub Manager is responsible for providing regulatory support to the International country and / or cluster Regulatory teams. The Hub Managers work across portfolio phases from initial applications, commercial lifecycle through to product withdrawal. They support numerous regulatory activities that include but are not limited to : M1 dossier components (local document authoring and / or coordination) Simple local only HA query responses Provide support for general x-functional support 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. This role acts as initial point of contact for assigned Country / Cluster under his / her responsibility for Country Regulatory Strategist, Hub Submission manager / Dossier Manager, and other key stakeholders involved in the processes described above. It is expected that this role partners closely with the Country Regulatory Strategist and Hub Submission / Dossier Managers to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to : Identification of regulatory requirements (for the in-scope submission categories defined) Authoring, delivery and / or coordination of local, submission-ready documents The quality review / approval of the Dossier provided by Hub Submission / Dossier Managers (for the in-scope submission categories defined) JOB RESPONSIBILITIES RIO Execution Hub manager is focused on end-to-end management of multi-regional, regional and national regulatory dossiers for assigned cluster / country / therapeutic area / products, both initial registration applications and ongoing lifecycle management through to product withdrawal. Key Accountabilities include : Ensure timely delivery of local M1 dossier components Act as the initial point of contact for assigned cluster / country under his / her responsibility for RIO Execution Hub Team Lead and key stakeholders Provide Regulatory support for x-functional support assigned to him / her to local affiliates for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning Requirements : B.S. / B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered Advanced to Fluent English language required. Multilingual skills desirable Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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