Job Summary
A biotechnology company is searching for a person to fill their position for a Remote Regulatory CMC Director.
Must be able to:
- Participate in the development of CMC regulatory strategy
- Deliver high-quality CMC submissions
- Build and manage relationships
Applicants must meet the following qualifications:
- 10 years of relevant Biologics experience in Regulatory Affairs CMC
- Experience in Biologics drug development, market applications and commercial lifecycle
- Demonstrated track record of successful preparation and submission to FDA/relevant agencies
- Ability to apply scientific principles to assess regulatory issues
