Manager I, Submission Management

Position Summary

The Manager, Submission Management supports end‑to‑end regulatory activities for assigned projects, including leading the preparation and compilation of compliant US IND and marketing complex submissions for global health authorities and supporting continuous improvement initiatives.

Position Responsibilities

Regulatory (IND and Marketing) Submission Management

• Collaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
• Collaborate with teams to drive the execution of the Global Submission Plan.
• Track and ensure timely progress of eCTD submission components to Health Authorities. Apply risk and critical path management practices.
• Execute submission management and publishing activities in the eCTD publishing system for efficient eCTD production and delivery to HA portals.
• Lea...