Executive Director, Global Regulatory Affairs Cmc Early Development

Takeda

Boston, MA, USA
Base: $238,000.00 - $374,000.00; bonus/equity: not...
Hybrid
Global cmc regulatory strategy
Early development regulatory strategy
Health authority interactions
Provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development

Job Summary

  • Provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development.
  • Serve as an influential leader internally and externally, shaping early-development CMC regulatory policy, influencing cross-functional decision-making, and advancing adoption of in silico and digital approaches to product and process development across major regions.
  • Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do, fostering an inclusive, collaborative workplace.

Matching Summary

Provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development.

Salary

Base: $238,000.00 - $374,000.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision insurance, 401(k) plan and company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, sick time, paid vacation

Skills & Requirements

Must-have

  • Global CMC regulatory strategy
  • Early development regulatory strategy
  • Health authority interactions
  • CMC content quality and compliance
  • Regulatory policy shaping

Nice-to-have

  • In silico approaches and digital capabilities
  • Cross-functional leadership
  • Business development and due diligence

Key Requirements

  • Advanced degree in scientific or engineering discipline
  • 20+ years industry experience
  • Significant Global Regulatory Affairs CMC experience
  • Leadership for small molecule/biologic products
  • Experience authoring/managing CMC content
  • Strong working knowledge of CMC development and global regulatory requirements

Work Rights

Not specified

Tailored Resume

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