Director, Regulatory Cmc

Calicolabs

South San Francisco, CA, United States
Base: $275,000 - $280,000; bonus/equity: two annua...
On-site
Global cmc regulatory strategies
Small molecules and monoclonal antibodies
Cmc content for investigational and marketing applications
Calico is an Alphabet-founded research and development company focused on understanding the biology of aging to devise interventions for longer and healthier lives

Job Summary

  • Calico is an Alphabet-founded research and development company focused on understanding the biology of aging to devise interventions for longer and healthier lives.
  • The Director of Regulatory CMC will lead global CMC regulatory strategies for small molecules and monoclonal antibodies, ensuring compliance across the product lifecycle.
  • This role requires deep scientific fluency, meticulous attention to detail, and the ability to negotiate effectively with global health authorities.

Matching Summary

Calico is an Alphabet-founded research and development company focused on understanding the biology of aging to devise interventions for longer and healthier lives.

Salary

Base: $275,000 - $280,000; Bonus/Equity: Two annual cash bonuses; Benefits: Not specified

Skills & Requirements

Must-have

  • Global CMC regulatory strategies
  • Small molecules and monoclonal antibodies
  • CMC content for investigational and marketing applications
  • Interactions with FDA, EMA, and global health authorities
  • Authoring CMC sections for global filings
  • Cross-functional collaboration with Process Development, Analytical Development, and Quality Assurance
  • Monitoring evolving CMC regulations

Nice-to-have

  • Inspiring and exciting place for medical breakthroughs
  • Curiosity-driven discovery science
  • Vibrant drug-development pipeline

Key Requirements

  • B.S./M.S. in scientific discipline; Ph.D. or PharmD highly preferred
  • 10+ years biopharmaceutical industry experience
  • 7+ years focused on CMC Regulatory Affairs
  • Track record of contributing to major marketing application (NDA or BLA)
  • Strong understanding of GMP and ICH guidelines
  • Deep knowledge of small molecule and mAbs modalities
  • Ability to interpret complex technical data
  • Deep knowledge of FDA, EMA, ICH regulations
  • Exceptional communication and interpersonal skills
  • Willing to work onsite at least four days per week

Work Rights

Not specified

Tailored Resume

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