RIO Execution Hub Manager (Manager / Sr. Manager)

• 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

• 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)

• 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, including the Country Regulatory Strategist and Hub Submission manager, for the processes under his/her responsibility
• 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
• Provide support for local audit readiness activities including audit interviews as needed, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as required
• Support country regulatory strategists with country x-functional meetings e.g., on launch plans, as required
• Perform Quality review/approval of the Dossier build Table of Contents provided by Hub Submission/Dossier Managers (for the in-scope submissions under his/her responsibility)
• Partner with Grow submission managers and Regional Submission Hubs to deliver

• Growth applications to meet International Commercial knots prioritisation and Op plans
• Support RIO and International Regional Leadership partnering with Submission Hubs for

• International Commercial knot prioritisation discussions for Op plan cycle
• GRS lifecycle prioritisation discussions for CMC and Labelling changes

• Author and review of M1 local documents (cover letters, variations, MA applications), and relevant translations
• May engage with Labeling Hubs and clusters/countries on Labels and Artwork updates to include local requirements, ensuring alignment with approved text and supporting launch activities
• Support clusters/countries with authoring of simple HA query responses e.g., admin related requests, and coordinate with relevant SMEs/functions (e.g., CMC) to address more complex HA queries, based on CRS query response strategy

• Provides regulatory support to simple and complex regulatory activities in the assigned country/cluster (e.g., Initial applications, commercial lifecycle through to product withdrawal, tenders, audits, launch planning) and applies technical experience to impact business results
• Lead regulatory support to countries/clusters with challenging internal and external constraints
• Acts as a regulatory matter expert with extensive regulatory expertise working across different clusters and/or regions to consolidate Regulatory activity, with close matrix collaboration with strategists and other local and above country cross-functional stakeholders

• Represents the RIO function and plays key roles in RIO, GI&PE and GRS improvement projects

• Leadership of complex regulatory activities to support different clusters, regions (e.g., major submissions or national portfolios, tenders, audits, launching plans) and application of domain experience to influence business results
• Involvement in visible and timebound complex and/or high volume projects with pan regional impact with challenging constraints

• Leads continuous improvement projects that impact people, technology, and/or processes within RIO Hubs, and/or represent RIO playing key leadership roles in transformation projects in broader GI&PE and GRS

• 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
• Advanced Microsoft Office Suite skills
• Familiarity with pharmaceutical organizational structures, systems, and culture
• An understanding of country/cluster regulatory requirements and trends is preferred
• Relevant experience within pharma, in Regulatory, quality and/or compliance fields

• A colleague who does not require management oversight on daily work, self-initiates problem solving and is able to navigate ambiguous situations impacting GRS and beyond through to results. Recognizes when escalation/status updates are required
• Demonstrates domain expertise which drives execution in complex submission strategies and impacts outcomes on business results
• Demonstrated experience in matrix management where the colleague does not have autonomy
• Pre-empts internal / external risk to organization and raises/ partners to mitigate

• A colleague who does not require management oversight on daily work, self-initiates problem solving and is able to navigate ambiguous situations impacting RIO, GI&PE and/or GRS and beyond through to results. Recognizes when escalation is required.
• Demonstrates domain expertise which drives execution in complex submission strategies and impacts outcomes on business results
• Demonstrated experience in matrix management where the colleague does not have autonomy
• Pre-empts internal / external risk to organization and raises/ partners to mitigate

• Country/Cluster teams, Submission Manager hubs and other functions across RIO
• GIPE, GRS broader organization RIO Execution Hub Manager can interact with Local affiliate cross functional teams for BAU well defined M1 local components (e.g. Medical, Safety, Clinical, DRSD). informing or via the Country Regulatory team per agreements established

• Project specific resources

Pfizer