All-Cycle Regulatory & International Operations (RIO) Execution Hub Manager / Sr. Manager

Multiple Positions Available

JOB SUMMARY

The RIO Execution Hub Manager is responsible for providing end-to-end 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

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

JOB RESPONSIBILITIES

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

General accountabilities (For reference only):

• 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

Local document authoring & submission prep (For reference only)

• Author and review of M1 local documents (cover letters, variations, MA applications), and relevant translations