Regulatory Affairs Regional Project Manager (remote role)

The role is a fixed term contractor for 1-4 years.

Overview

Participate in MSA project workstream. Regulatory planning globally and alongside other functions within ORD and OMS (e.g., supply, EtE planning and PSM) including efficiency and optimization/simplification strategies. Leads supply optimization discussions (stock build/stock depletion/registration deletion/commercialization of validation batches). Sets up priorities, organizes, oversees and monitors activities, towards division’s and country's objectives achievement in compliance with policies and standards.

Responsibilities

• Lead and coordinates end-to-end regulatory process for supply chain changes as per guidelines for the APJ (including China) region as well as regulatory requirements from other regions globally.
• Support timely and compliant submission management from RA perspective as well as cross-functionally.
• Support planning and project management including K...