Manager, Regulatory Affairs

Role Overview

The Regulatory Affairs Manager supports the development and execution of regulatory strategies to enable the successful development of biological products. This role is responsible for coordinating, compiling, and reviewing initial health authority submissions, as well as the preparation of timely, high-quality responses to health authority questions. The Manager ensures regulatory requirements are understood and incorporated into program activities while maintaining compliance with global regulations and internal standards. The Regulatory Manager will have recognition as a leading role in their assigned programs, and will work with support and guidance from senior regulatory management as needed.

Key Responsibilities

• Drives timely submission of regulatory submissions including initial trial applications (e.g. IND, CTA) and marketing applications, and the documentation required to maintain these applications.
• Draft, edit, and review regulatory documents such as meeting requests, query responses, and submission modules.
• Conduct regulatory review of product documentation intended for submissions to ensure accuracy, consistency, and compliance with FDA and