Director, Regulatory Site Cmc

Takeda

Boston, MA, United States
Base: $174,500.00 - $274,230.00; bonus/equity: not...
Hybrid
Regulatory cmc experience
Global ha requirements
Post-approval change management
The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level

Job Summary

  • The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level.
  • This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes.
  • At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Matching Summary

The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level.

Salary

Base: $174,500.00 - $274,230.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Regulatory CMC experience
  • Global HA requirements
  • Post-approval change management

Nice-to-have

  • Leadership and collaboration skills
  • Problem-solving ability
  • Inclusive culture promotion

Key Requirements

  • 10+ years of biopharmaceutical experience
  • 8+ years of Regulatory CMC experience
  • BS/BA in a Scientific Discipline

Work Rights

Not specified

Tailored Resume

Cover Letter