Associate Director, Regulatory Affairs, Cmc

Artiva

San Diego, California, United States
Base: $185,000 - $200,000; bonus/equity: not speci...
Hybrid
Late-stage and commercial cmc regulatory experience
Authoring bla/maa module 3/ctd dossiers
Experience with ema maa and anvisa submissions
The role supports late-stage development, commercial launch, and lifecycle management for Artiva Biotherapeutics' cell therapy pipeline

Job Summary

  • The role supports late-stage development, commercial launch, and lifecycle management for Artiva Biotherapeutics' cell therapy pipeline.
  • Candidates must be strong independent authors capable of producing scientifically rigorous CMC regulatory submissions including BLAs and MAAs.
  • The position offers a comprehensive benefits package including medical, dental, vision, 401(k), and paid time off in a collaborative environment.

Matching Summary

The role supports late-stage development, commercial launch, and lifecycle management for Artiva Biotherapeutics' cell therapy pipeline.

Salary

Base: $185,000 - $200,000; Bonus/Equity: Not specified; Benefits: Medical, Dental, Vision, 401(k), PTO

Skills & Requirements

Must-have

  • Late-stage and commercial CMC regulatory experience
  • Authoring BLA/MAA Module 3/CTD dossiers
  • Experience with EMA MAA and ANVISA submissions
  • Cell therapy allogeneic and autologous platform knowledge
  • Managing health authority meeting interactions

Nice-to-have

  • Familiarity with Health Canada and PMDA regulations
  • Experience across both allogeneic and autologous platforms
  • Informal mentorship of junior regulatory staff
  • Knowledge of ICH Q5-Q12 series guidelines

Key Requirements

  • Bachelor's degree required; advanced degree preferred
  • Proven track record authoring BLA/MAA submissions
  • Hands-on experience with ex-US regulatory submissions
  • Strong written communication skills for regulatory documents

Work Rights

Not specified

Tailored Resume

Cover Letter