Senior Specialist, Submission Management

Position Summary

Senior Specialist Submission Management supports end-to-end regulatory activities for assigned projects, including executing the preparation and compilation of compliant US IND and marketing maintenance submissions for global health authorities.

Responsibilities

• Collaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
• Collaborate with teams to execute the Global Submission Plan.
• Track and ensure timely progress of submission components to Health Authorities.
• Execute submission management and publishing activities in the eCTD publishing tool for efficient eCTD production and delivery through HA portals.
• Represent team in regulatory/submission meetings driving deliverable and publishing timelines.
• Participate in department initiatives within scope.
• Execute required activities in ...