Regulatory Submissions Associate Manager II - APAC

Job Overview

In the role you will collaborate with key stakeholders across the organization and at times be client facing to achieve client-centric delivery in a matrix organization. Oversight and accountability of Regulatory Authority (RA), Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions for designated clinical trial projects across the APAC region is the key objective.

Summary of Responsibilities

• Oversight and accountability for RA, IRB/EC, and Third Body submissions, including submission strategy, timeline, planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones within relevant systems. Coordinate responses to queries and ensure the required timelines are met. Provides consolidated country requirements and regular status updates to project team and Client, as applicable. May be assigned to smaller projects in terms of size and complexity in reg...