Position Overview

The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. This role assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements.

Essential Duties

Include but are not limited to the following: