Rio Execution Hub Manager

JOB SUMMARY

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, through the commercial lifecycle, to product withdrawal. They support various regulatory activities, including but not limited to:
• M1 dossier components (local document authoring and/or coordination)
• Simple local-only HA query responses
• Providing support for general cross-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 the initial point of contact for the assigned country/cluster under his/her responsibility, liaising with the country regulatory strategist, hub submission manager/dossier manager, and other key stakeholders.

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. Responsibilities include but are not limited to:

• Identification of regulatory requirements (for the in-scope submission categories)
• Authoring, delivery, and/or coordination of local, submission-ready documents
• Quality review/approval of the dossier provided by hub submission/dossier managers (for the in-scope submission categories)

The RIO Execution Hub Manager manages end-to-end regulatory dossiers for multiple regions, focusing on initial registration and ongoing lifecycle management until product withdrawal. The role involves engaging with functions to ensure operational efficiency and compliance.

Success is measured by the timeliness, quality, compliance, and efficiency of deliverables, aiming to bring organizational efficiencies.

Depending on the region/cluster, the manager may also serve as the Hub Submission Manager or partner closely with one.

General accountabilities (for reference only):

• Ensure timely delivery of local M1 dossier components
• Act as the initial contact point for the assigned cluster/country for the RIO execution team and key stakeholders
• Provide regulatory support for cross-functional activities related to tenders, out-of-stock reporting, product reviews, risk plans, and launch coordination
• Support audit readiness activities, including audit interviews, DHPC responses, and medical info requests
• Assist country strategists with cross-functional meetings on launch plans
• Perform quality review/approval of dossier build tables of contents
• Partner with growth submission managers and regional hubs to deliver growth applications and support international commercial priorities
• Support lifecycle prioritization discussions and local document authoring for applications and variations
• Coordinate with labeling hubs on label and artwork updates
• Assist with simple HA query responses and coordinate with SMEs for complex queries

• Provide regulatory support across the product lifecycle, applying technical expertise to impact business results
• Lead regulatory support in challenging environments
• Act as a regulatory expert across clusters/regions, consolidating activities and collaborating with cross-functional teams

• Represent RIO in improvement projects and leadership roles within transformation initiatives

• B.S./B.Sc. in Pharmacy, Life Sciences, Business, or IT; relevant experience considered
• Fluent English required; multilingual skills are a plus
• Proven ability to learn new software, regulations, and standards
• Advanced MS Office skills
• Understanding of pharmaceutical organizational structures and regulations
• Experience in pharma regulatory, quality, or compliance fields

• Self-initiating, problem-solving, able to navigate ambiguity, and recognize when escalation is needed
• Domain expertise that drives execution and impacts business outcomes
• Experience in matrix management and risk mitigation

Pfizer is an equal opportunity employer and complies with all applicable legislation in each jurisdiction.