Associate Director, Global Regulatory Affairs

Company Name: Takeda

Job Overview

The Associate Director, Global Regulatory Affairs at Takeda develops innovative global regulatory strategies and provides strategic guidance for product development. This role involves leading Global Regulatory Teams (GRTs) and representing regulatory functions on Global Program Teams.

Key Responsibilities

• Defining and leading global strategies
• Managing US FDA submissions and approvals
• Acting as a direct point of contact with the FDA
• Managing direct reports

Position Requirements

The position requires:

• Understanding scientific data
• Anticipating risks
• Ensuring global regulatory compliance