Director, Regulatory Operations

Keros Therapeutics

Lexington, United States
Base: $206,000 - $227,000 usd annually; bonus/equi...
On-site
Veeva vault rim system expertise
Ectd submission publishing experience
Health authority correspondence management
The role involves establishing the Regulatory Operations function to support Keros' mission of developing therapies for TGF-β related disorders

Job Summary

  • The role involves establishing the Regulatory Operations function to support Keros' mission of developing therapies for TGF-β related disorders.
  • Key responsibilities include managing Veeva Vault RIM, overseeing eCTD publishing for major submissions like IND and BLA, and leading training initiatives.
  • The position requires partnering with IT and Quality teams to ensure system validation while maintaining proficiency in global regulatory guidelines.

Matching Summary

The role involves establishing the Regulatory Operations function to support Keros' mission of developing therapies for TGF-β related disorders.

Salary

Base: $206,000 - $227,000 USD annually; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Veeva Vault RIM system expertise
  • eCTD submission publishing experience
  • Health Authority correspondence management
  • Regulatory standards and SOP development
  • System validation with IT and Quality

Nice-to-have

  • Experience in fast-paced biotech environment
  • Strong multi-disciplinary team collaboration
  • Vendor management capabilities
  • Training strategy implementation skills

Key Requirements

  • 12+ years industry experience
  • 7+ years regulatory operations experience
  • BA/BS degree or equivalent
  • Extensive knowledge of eCTD systems
  • Proficiency in MS Office and Adobe Acrobat

Work Rights

Not specified

Tailored Resume

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