Job Summary
The RIO Execution Hub Manager is responsible for providing regulatory support to the International country and/or cluster Regulatory teams across the portfolio lifecycle—from initial applications through commercial life cycle and product withdrawal.
Key Responsibilities
- Act as the initial point of contact for the assigned country/cluster with Country Regulatory Strategist, Hub Submission/Dossier Manager, and key stakeholders.
- Provide regulatory support for local document authoring, HA query responses, tender support, out‑of‑stock reporting, Annual Product Quality Review, risk‑minimization plans, and launch‑planning regulatory input.
- Identify regulatory requirements for the in‑scope submission categories.
- Author, deliver, and coordinate local, submission‑ready documents.
- Perform quality review/approval of dossier builds and Table of Contents submitted by Hub Submission/Dossier Managers.