RIO Execution Hub Manager

JOB INFORMATION

JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.

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 and

• The quality review/approval of the Dossier provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined).

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JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

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. Associated functions are engaged to provide smooth operational performance and process efficiency.

This role executes the GRS mission by delivering against goals executing initiatives implementing new opportunities and filling gaps related to the production of regulatory International and operational support. A key component of this role is the implementation of portfolio execution efficiencies identification and escalation of quality and compliance issues or emerging risks detected during the management of the Cluster/Country portfolio under his/her responsibility.

Success in this role is measured by the timeliness quality compliance and efficient delivery of critical on-the-job deliverables bringing efficiencies to the organization.

In some regions/clusters the RIO Execution Hub manager can execute the role of Hub Submission Manager while in others should closely partner with Hub Submission Manager.

Key Accountabilities include:

General accountabilities (For reference only)

• Ensure timely delivery of local M1 dossier components

• Act as the initial point of contact for 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 meetInternational Commercial knots prioritisationand Op plans.
• Support RIO andInternationalRegional Leadershippartnering with Submission Hubs for
  • International Commercial knotprioritisationdiscussions for Op plan cycle.
  • GRS lifecycle prioritisation discussions for CMC and Labelling changes

Local document authoring & submission prep (For reference only)

• 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.

Manager

Business Experiences:

• 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.

Non-Portfolio Experiences:

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

Senior Manager

Business Experiences:

• 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.

Non-Portfolio Experiences:

• 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.

QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education relevant experience licenses certifications and other job-related technical and managerial skills.

B.S./. 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.

Working habits (qualitative examples)

Manager

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.

Senior Manager

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

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.

RIO Execution Hub Manager

Interacts with

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

RESOURCES MANAGED

Summary of resources managed.

Project specific resources

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