Job Summary

A gene therapy development company is filling a position for a Remote Senior CMC Regulatory Science Manager.

Must be able to:

• Plan, prepare and submit high quality CMC modules of investigational and marketing authorization filings
• Participate on the assessment an communication of regulatory risks associated with assigned program(s)
• Participate in definition and implementation of CMC regulatory strategy for assigned program(s)

Qualifications Include:

• Experience authoring CMC documents and supporting health authority communications
• Significant (4 - 6 years) regulatory CMC experience including program support
• Successful experience in supporting/independently leading Module 3 sections for investigational and marketing applications
• Good understanding of manufacturing, testing and regulation of pharmaceutical products
• Experience leading CMC-focused meetings is a must