Cmc Biopharma Regulatory Consultant — Ecolab Life Sciences

Ecolab Pty Ltd

Pennsylvania, United States
Base: $153,900.00 - $230,800.00; bonus/equity: eli...
Cmc regulatory filing expertise
Downstream purification knowledge
Global regulatory strategy leadership
Ecolab Life Sciences is a global leader dedicated to helping biopharmaceutical manufacturers achieve excellence in safety, compliance, and operational performance

Job Summary

  • Ecolab Life Sciences is a global leader dedicated to helping biopharmaceutical manufacturers achieve excellence in safety, compliance, and operational performance.
  • The Global Biopharma Regulatory Consultant will play a key role in supporting global biopharma customers with regulatory filings and interactions with governmental authorities.
  • This position offers a competitive base salary with eligibility for annual bonus pay based on performance and comprehensive benefits.

Matching Summary

Ecolab Life Sciences is a global leader dedicated to helping biopharmaceutical manufacturers achieve excellence in safety, compliance, and operational performance.

Salary

Base: $153,900.00 - $230,800.00; Bonus/Equity: Eligible for annual bonus; Benefits: Comprehensive and market-competitive

Skills & Requirements

Must-have

  • CMC regulatory filing expertise
  • Downstream purification knowledge
  • Global regulatory strategy leadership
  • Cross-functional collaboration
  • Regulatory submissions support
  • Travel availability up to 50%

Nice-to-have

  • Advanced degree in Life Sciences
  • Experience authoring IND/BLA or PACMP
  • Strong communication and advocacy skills
  • Collaboration with commercial teams

Key Requirements

  • Bachelor's degree
  • 10 years of biopharma CMC regulatory experience
  • Experience with FDA and European regulatory agencies
  • Ability to travel at least 50%
  • Immigration sponsorship not available

Work Rights

Not specified

Tailored Resume

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