RIO Execution Hub Manager (Manager / Sr. Manager)

<u><b><i>Multiple Positions Available</i></b></u><p><b><u>JOB SUMMARY</u></b></p><p>The RIO Execution Hub Manager is responsible for providing regulatory support to the International country and/or cluster Regulatory teams.</p><p></p><p>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:</p><ul><li>M1 dossier components (local document authoring and/or coordination</li><li>Simple local only HA query responses</li><li>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</li></ul><p></p><p>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.</p><p></p><p>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:</p><ul><li>Identification of regulatory requirements (for the in-scope submission categories defined)</li><li>Authoring, delivery and/or coordination of local, submission-ready documents</li><li>The quality review/approval of the Dossier provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined)</li></ul><p></p><p><b><u>JOB RESPONSIBILITIES </u></b></p><p>RIO Execution Hub manager is focused on end-to-end management of multi-regional, regional and national regulatory dossiers for assigned <span>cluster/country/therapeutic</span> 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.</p><p></p><p>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 <span>responsibility. </span></p><p>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.</p><p></p><p>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.</p><p></p><p><b><u>KEY ACCOUNTABILITIES</u></b></p><p><b>General accountabilities (For reference only):</b></p><ul><li>Ensure timely delivery of local M1 dossier components</li><li>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</li><li>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</li><li>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</li><li>Support country regulatory strategists with country x-functional meetings e.g., on launch plans, as required</li><li>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)</li><li>Partner with Grow submission managers and Regional Submission Hubs to deliver<ul><li>Growth applications to meet International Commercial knots prioritisation and Op plans</li></ul></li><li>Support RIO and International Regional Leadership partnering with Submission Hubs for<ul><li>International Commercial knot prioritisation discussions for Op plan cycle</li><li>GRS lifecycle prioritisation discussions for CMC and Labelling changes</li></ul></li></ul><p></p><p>Local document authoring &amp; submission prep (For reference only)</p><ul><li>Author and review of M1 local documents (cover letters, variations, MA applications), and relevant translations</li><li>May engage with Labeling Hubs and clusters/countries on Labels and Artwork updates to include local requirements, ensuring alignment with approved text