Global Head Of Regulatory Affairs

Azurity Pharmaceuticals

Raleigh, NC, United States
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Develop global regulatory strategies
Oversee regional regulatory leads
Ensure global regulatory compliance
** Azurity Pharmaceuticals is seeking a Global Head of Regulatory Affairs in Raleigh, NC. The ideal candidate will have extensive experience in regulatory affairs, particularly in overseeing global regulatory strategies and submissions. **

Job Summary

  • Empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.
  • Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan.
  • Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.

Matching Summary

Match Score: 75

** Azurity Pharmaceuticals is seeking a Global Head of Regulatory Affairs in Raleigh, NC. The ideal candidate will have extensive experience in regulatory affairs, particularly in overseeing global regulatory strategies and submissions. **

Skills & Requirements

Must-have

  • Develop global regulatory strategies
  • Oversee regional regulatory leads
  • Ensure global regulatory compliance
  • Lead cross-functional initiatives
  • Manage multiple complex projects
  • Interact with regulatory authorities

Nice-to-have

  • Patient-centric product focus
  • Innovative product development
  • Fast-growing organization
  • Positive attitude and integrity

Key Requirements

  • 15+ years of experience in Regulatory Affairs
  • MD, PhD or PharmD in a scientific discipline preferred
  • Proven success in regulatory submissions
  • FDA, EU, Canada, ROW, and post-marketing experience
  • Experience with investigational and marketed products
  • CRO management experience preferred

Work Rights

Not specified

Tailored Resume

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