Regulatory Execution Hub Team Lead

The RIO Execution Hub Team Lead is responsible for leading the Hub Coordinators and Managers who provide regulatory support to the country and/or cluster Regulatory teams.   The Execution Hub Coordinators and Managers that report to this role, 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, including Labels & Artwork), Simple local only HA query responses, Provide Regulatory support for general x-functional support to local affiliates for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization communications, and coordination of regulatory input for launch planning.     This role acts as the initial point of contact for assigned cluster/countries for issue resolution and escalation for the processes described above.   It is expected that this role partners closely with the RIO Submissions Hub Team Manager to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to Identification of regulatory requirements identification (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).   In some regions/clusters, the RIO Execution Hub Team Lead can manage the Hub Submission Managers, while in others, RIO Execution Hub Team Lead should closely partner with Regional Submission Hub Team manager.

Lead designated resources focused on end-to-end management of multi-regional, regional and national regulatory dossiers for assigned cluster/country, both initial applications and ongoing lifecycle through to product withdrawal. Associated functions are engaged to provide smooth operational performance and process efficiency.   This role supports implementation of the GRS mission by contributing to the definition and delivery against goals, executing initiatives, identifying and capitalizing on new opportunities, and filling gaps related to the production of regulatory International and operational support. A key component of this role is the proactive pursuit of portfolio execution efficiencies, identification of quality and compliance issues or emerging risks through establishment of methodologies to provide real time portfolio data.  Success in the role is expected to deliver measurable efficiencies for the organization. Key Accountabilities include: General accountabilities (For reference only) Lead RIO Execution Hub Coordinators & Managers to ensure timely delivery of local M1 dossier components Act as the initial point of contact for assigned cluster/country for issue resolution, escalation, and performance monitoring of the responsibilities under RIO Execution Hubs teams. Provide Regulatory support for general x-functional support to local affiliates for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization communications, and coordination of regulatory input for launch planning. Provide technical leadership for execution of local audit readiness activities including audit interviews as needed, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as required. Oversee any input for country cross-functional meetings e.g., on launch plans as required. Oversee the Quality review/approval of the Dossier build Table of Contents provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined). Oversee partnering with Growth submission managers and Regional Submission Hubs to deliver  Growth applications to meet International Commercial knots prioritisation and Op plans. Support RIO and International Regional