Associate Director, Global Regulatory Affairs Cmc

Takeda

Boston, MA, US
Base: $154,400.00 - $242,550.00; bonus/equity: sho...
Hybrid
10+ years biopharmaceutical industry experience
5+ years regulatory cmc or device experience
Leading major variation or amendment projects
This role within the Global Regulatory Affairs organization contributes to delivering critical functions by developing and leading regulatory CMC strategies with minimal supervision

Job Summary

  • This role within the Global Regulatory Affairs organization contributes to delivering critical functions by developing and leading regulatory CMC strategies with minimal supervision.
  • The position requires independent definition of CMC content requirements for regulatory submissions and ensuring conformance with established global regulatory standards.
  • Takeda offers a hybrid work environment with competitive compensation ranging from $154,400.00 to $242,550.00, along with comprehensive benefits including medical insurance and 401(k) matching.

Matching Summary

This role within the Global Regulatory Affairs organization contributes to delivering critical functions by developing and leading regulatory CMC strategies with minimal supervision.

Salary

Base: $154,400.00 - $242,550.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off

Skills & Requirements

Must-have

  • 10+ years biopharmaceutical industry experience
  • 5+ years Regulatory CMC or Device experience
  • Leading major variation or amendment projects
  • Supporting initial IND/IMPD preparation
  • Supporting initial NDA/BLA submission

Nice-to-have

  • Advanced degree in scientific discipline
  • Experience in Pharmaceutical Development
  • Strong analytical process understanding
  • Proactive communication skills
  • Inclusive culture promotion

Key Requirements

  • BS/BA Degree in Scientific Discipline
  • M.S., Ph.D. preferred
  • 10+ years overall biopharma experience
  • 5+ years Regulatory CMC experience
  • Experience leading major variations or amendments

Work Rights

Not specified

Tailored Resume

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