Job Summary
A staffing and recruitment agency is in need of a Remote Regulatory Affairs CMC Director.
Core Responsibilities of this position include:
- Assisting with the planning, writing and critical review of pre-INDs, INDs, IMPDs, BLAs, MAAs etc
- Assisting in the development of CMC strategies
Skills and Requirements Include:
- Bachelor of Science degree
- 8+ years of industry experience in US regulatory CMC activities
- Knowledge of global regulatory requirements
- Previous hands-on experience authoring regulatory documents
- Must be able to demonstrate the ability to apply knowledge strategically and operationally across all projects
