Head Of Global Regulatory Affairs (biolife Plasma)

BioLife Plasma Services

Bannockburn, IL, USA
Base: $259,000.00 - $407,000.00; bonus/equity: not...
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Global regulatory strategy
Plasma sourcing and collection
Medical devices
** BioLife Plasma Services is seeking a Head of Global Regulatory Affairs to oversee regulatory strategy and compliance across its plasma sourcing and collection initiatives. The ideal candidate will have extensive experience in global regulatory affairs, particularly within biologics and medical devices, and will engage with global health authorities to drive innovation and operational excellence. **

Job Summary

  • 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.
  • 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.
  • BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Limited, is an industry leader in the collection of high-quality plasma, which is processed into life-saving plasma-based therapies.

Matching Summary

Match Score: 75

** BioLife Plasma Services is seeking a Head of Global Regulatory Affairs to oversee regulatory strategy and compliance across its plasma sourcing and collection initiatives. The ideal candidate will have extensive experience in global regulatory affairs, particularly within biologics and medical devices, and will engage with global health authorities to drive innovation and operational excellence. **

Salary

Base: $259,000.00 - $407,000.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 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 regulatory strategy
  • Plasma sourcing and collection
  • Medical devices
  • Donor interaction systems
  • Health authority engagement
  • Regulatory policy influence

Nice-to-have

  • Disruptive thinker
  • Process and systems innovation
  • Executive spokesperson
  • Cross-functional collaboration

Key Requirements

  • 15+ years in healthcare
  • Senior-level global regulatory affairs experience
  • Biologics, plasma, medical devices, digital health
  • Engaging with FDA and global health authorities
  • Leading through transformation and complexity
  • Bachelor's degree required
  • Advanced degree preferred

Work Rights

Not specified

Tailored Resume

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