Remote Senior CMC Regulatory Science Manager

Location: East Coast

Compensation: To Be Discussed

Staff Reviewed: Thu, Jul 08, 2021

This job expires in: 12 days

Job Category: Healthcare

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Education Level: Doctorate

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

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