Global Head Of Biolife Regulatory Affairs (plasma, Devices And Transformation)

Takeda

Bannockburn, IL, USA
Base: $259,000.00 - $407,000.00; bonus/equity: u.s...
Hybrid
Global regulatory strategy
Plasma sourcing and collection
Medical devices and digital systems
This role ensures that the regulatory strategy enables innovation, operational excellence, and long-term plasma supply resilience, while maintaining compliance with global health authority requirements

Job Summary

  • This role ensures that the regulatory strategy enables innovation, operational excellence, and long-term plasma supply resilience, while maintaining compliance with global health authority requirements.
  • The Global Head of BioLife Regulatory is an enterprise regulatory leader responsible for defining and executing global regulatory strategy across BioLife plasma sourcing, collection, diversification, medical devices, donor interaction systems (DIS), and plasma center transformation initiatives.
  • U.S. based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, and other benefits.

Matching Summary

This role ensures that the regulatory strategy enables innovation, operational excellence, and long-term plasma supply resilience, while maintaining compliance with global health authority requirements.

Salary

Base: $259,000.00 - $407,000.00; Bonus/Equity: U.S. based employees may be eligible for short-term and/or long-term incentives; 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

Skills & Requirements

Must-have

  • Global regulatory strategy
  • Plasma sourcing and collection
  • Medical devices and digital systems
  • Health authority engagement
  • Cross-functional collaboration

Nice-to-have

  • Disruptive thinker
  • Influence without authority
  • Executive spokesperson
  • Proactive regulatory strategy

Key Requirements

  • 15+ years in healthcare
  • Senior-level global regulatory affairs experience
  • Experience with biologics, plasma, medical devices, digital health
  • Demonstrated FDA and global health authority engagement
  • Proven ability to lead through transformation and complexity

Work Rights

Not specified

Tailored Resume

Cover Letter