RIO Execution Hub Sr Associate 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 submissions 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.

Key Accountabilities include:





General Accountabilities (For Reference Only)

• Ensure timely delivery of local M1 dossier components
• 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).
• Can provide support for simple tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and regulatory information status for launch planning.
• Provide support for local audit readiness activities, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as requested
• Parther with Grow submission managers and Regional Submission Hubs to meet growth application delivery in line with International Commercial knots prioritisation and OP plans.
• Partner with Submission Hubs to meet GRS lifecycle prioritisation for CMC and Labelling changes.

Local document auth

📌 RIO Execution Hub Sr. Associate (Ciudad de México)
🏢 Pfizer
📍 Ciudad de México