Director, Global Regulatory Affairs Cmc

Takeda

Boston, MA, US
Base: $177,000.00 - $278,080.00; bonus/equity: sho...
Hybrid
Global regulatory cmc strategy development
Leading major global registrational submissions
Health authority negotiation and meetings
This role involves independently developing regulatory CMC strategies and leading execution for assigned products within Takeda's Global Regulatory Affairs organization

Job Summary

  • This role involves independently developing regulatory CMC strategies and leading execution for assigned products within Takeda's Global Regulatory Affairs organization.
  • The successful candidate will represent Takeda in Health Authority meetings and drive preparation activities to ensure regulatory success for complex drug products.
  • Takeda offers a hybrid work environment with competitive compensation ranging from $177,000 to $278,080, along with comprehensive benefits including medical, dental, vision, and 401(k) matching.

Matching Summary

This role involves independently developing regulatory CMC strategies and leading execution for assigned products within Takeda's Global Regulatory Affairs organization.

Salary

Base: $177,000.00 - $278,080.00; 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

  • Global Regulatory CMC strategy development
  • Leading major global registrational submissions
  • Health Authority negotiation and meetings
  • Complex drug product registration experience
  • Regulatory compliance and risk management

Nice-to-have

  • Mentoring and coaching team members
  • Cross-functional collaboration skills
  • Strategic input into change control evaluation
  • Proactive communication of regulatory risks

Key Requirements

  • BS/BA Degree required; Advanced Degree (MS/PhD) required
  • 10+ years biopharmaceutical industry experience
  • 8+ years pharmaceutical Regulatory CMC experience
  • Experience preparing NDA/BLA/MAA submissions
  • Strong understanding of global drug development regulations

Work Rights

Not specified

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