Associate Director, Regulatory Cmc

Vaxcyte Inc

San Carlos, California, United States
Base: $180,000 - $210,500 (sf bay area); bonus/equ...
On-site
10 years vaccine or biotech experience
Bla submission authoring experience
Fda ema ich regulatory knowledge
Vaxcyte Inc is seeking an Associate Director of Regulatory CMC to lead the development and execution of global regulatory strategies for vaccine products. The role requires extensive experience in the biotech industry, particularly in regulatory submissions, and offers competitive compensation and benefits

Job Summary

  • This role involves developing and executing multi-product global regulatory CMC strategies for investigational products while leading the preparation of regulatory submissions.
  • The position requires managing interactions with Health Authorities and providing regulatory CMC guidance to various cross-functional teams to ensure compliance with global requirements.
  • Candidates will benefit from a competitive compensation package that includes comprehensive benefits and an equity component within a mission-driven culture.

Matching Summary

Match Score: 85

Vaxcyte Inc is seeking an Associate Director of Regulatory CMC to lead the development and execution of global regulatory strategies for vaccine products. The role requires extensive experience in the biotech industry, particularly in regulatory submissions, and offers competitive compensation and benefits.

Salary

Base: $180,000 - $210,500 (SF Bay Area); Bonus/Equity: Equity component included; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • 10 years vaccine or biotech experience
  • BLA submission authoring experience
  • FDA EMA ICH regulatory knowledge
  • CMC section preparation expertise
  • Health Authority interaction management

Nice-to-have

  • Post-approval supplement experience
  • Manufacturing development background
  • Veeva TrackWise software skills
  • Strategic problem-solving abilities
  • Open collaborative communication style

Key Requirements

  • Bachelor's degree in scientific discipline
  • Minimum 10 years industry experience
  • Prior BLA or IND/IMPD experience preferred
  • Advanced knowledge of FDA and EMA guidelines

Work Rights

Not specified

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