Associate Director, Regulatory Affairs Cmc And Devices

Jobgether

United States
On-site
Global cmc regulatory submissions
Biologic therapies
Clinical-stage biotechnology
This position is responsible for driving the preparation, coordination, and execution of global CMC regulatory submissions that support clinical development programs across multiple assets

Job Summary

  • This position is responsible for driving the preparation, coordination, and execution of global CMC regulatory submissions that support clinical development programs across multiple assets.
  • You will play a critical role in ensuring compliance with evolving global regulatory expectations while enabling timely progression of clinical trials.
  • This position requires close collaboration with technical operations, quality, and cross-functional regulatory teams, as well as external partners, to deliver high-quality, submission-ready documentation.

Matching Summary

This position is responsible for driving the preparation, coordination, and execution of global CMC regulatory submissions that support clinical development programs across multiple assets.

Skills & Requirements

Must-have

  • global CMC regulatory submissions
  • biologic therapies
  • clinical-stage biotechnology
  • drug-device combination products

Nice-to-have

  • science-driven environment
  • cross-functional coordination skills

Key Requirements

  • Associate Director level experience
  • Regulatory Affairs experience
  • CMC regulatory submissions
  • Device regulatory experience

Work Rights

Not specified

Tailored Resume

Cover Letter