Strategic Regulatory Portfolio Manager

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time

Job Summary:

The RIO Execution Hub Manager oversees regulatory support for International country and/or cluster Regulatory teams. They work across portfolio phases from initial applications, commercial lifecycle through to product withdrawal.

This role acts as the primary point of contact for assigned Country/Cluster under their responsibility for Country Regulatory Strategist, Hub Submission manager/Dossier Manager, and other key stakeholders involved in the processes described above.

Key responsibilities include ensuring timely delivery of local M1 dossier components, providing regulatory support for x-functional support assigned to them to local affiliates for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning.

They partner closely with the Country Regulatory Strategist and Hub Submission/Dossier Managers to enable timely, high-quality submissions and sustained compliance.

Responsibilities:

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.

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 their 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.

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