Job Summary
A biotechnology company is searching for a person to fill their position for a Remote Senior Regulatory CMC Clinical Manager.
Core Responsibilities Include:
- Providing regional and global strategic and operational regulatory CMC expertise and support in cross-functional teams
- Writing and/or Reviewing of regional and global CMC submission documents and responses to Health Authority questions
- Coordinating and completing regulatory assessments of CMC changes in the designated systems
Skills and Requirements Include:
- At least 5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity
- 3-5 years of experience in Regulatory CMC
- Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones
- BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science
