Overview

Our client (a gene therapy-focused biotech) is going through rapid growth and is looking for an Associate Director of Regulatory Affairs to join the organization in a permanent capacity.

In this role, you’ll also be taking the lead on regulatory submission activities – both for the FDA and international regulatory authorities. This will include leading documentation preparation as well as direct communication with the organizations on issues relating to drug development. Additionally, you will be developing and implementing the company’s regulatory strategy.

This is a fast-paced and highly collaborative team with a start-up feel so they are looking for someone who can jump in and hit the ground running.

Minimum Requirements/ Qualifications

  • 10 years of experience in clinical study management
  • Strong communication skills (both written and verbal)
  • Experience with the FDA and international regulatory authorities
  • Must be organized and detail-oriented

Tracking 3910

To Apply: https://www.jobg8.com/Traffic.aspx?1drb5Z1cGG0JiRJd%2fCy51gd