Job Summary
The RIO Execution Hub Manager provides regulatory support to international country and/or cluster regulatory teams. The role manages multi‑regional, regional and national regulatory dossiers across the product lifecycle, delivering high‑quality submissions and compliance.
Key Accountabilities
- Ensure timely delivery of local M1 dossier components.
- Act as initial point of contact for assigned clusters and countries with Country Regulatory Strategist and Hub Submission/Dossier Managers.
- Provide regulatory support for tenders, out‑of‑stock reporting, annual product quality review, risk minimization plans and regulatory input for launch planning.
- Support local audit readiness activities, respond to DHPC and medical information requests.
- Perform quality review and approval of dossier build Table of Contents and other submission‑ready documents.
- Partner with Hub Submission Managers and Region...