Senior Director, Global Regulatory Affairs

Zenasbio

Waltham, MA, United States
Base: $218,400 to $273,000; bonus/equity: annual p...
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Global regulatory strategy
Ind/cta/bla/maa submissions
Regulatory cmc collaboration
** Zenasbio is seeking a Senior Director of Global Regulatory Affairs to lead regulatory strategy for their late-phase investigational products in the autoimmune disease sector. The ideal candidate will possess extensive regulatory affairs experience in the pharmaceutical or biotechnology industries, demonstrating strong leadership and communication skills. **

Job Summary

  • The Senior Director, Regulatory Affairs will lead and oversee global filings including US and EU for a multi-indication late phase investigational product.
  • This role involves developing and executing global regulatory strategy, preparing/coordinating/reviewing submission content, and serving as the primary interface with Regulatory CROs.
  • The company is seeking top talent committed to patients with a track record of success in acquiring, developing, and commercializing products globally.

Matching Summary

Match Score: 75

** Zenasbio is seeking a Senior Director of Global Regulatory Affairs to lead regulatory strategy for their late-phase investigational products in the autoimmune disease sector. The ideal candidate will possess extensive regulatory affairs experience in the pharmaceutical or biotechnology industries, demonstrating strong leadership and communication skills. **

Salary

Base: $218,400 to $273,000; Bonus/Equity: Annual performance bonus, equity; Benefits: Full range of benefits

Skills & Requirements

Must-have

  • Global regulatory strategy
  • IND/CTA/BLA/MAA submissions
  • Regulatory CMC collaboration
  • Regulatory intelligence
  • Cross-functional team leadership

Nice-to-have

  • Fast-paced learning environment
  • TRUE Innovation values
  • Startup culture adaptability
  • Problem-solving ability

Key Requirements

  • 10-12 years regulatory affairs experience
  • Prior late phase experience
  • Marketing application filing experience
  • Biologics development knowledge
  • BS or advanced degree in life/physical sciences

Work Rights

Not specified

Tailored Resume

Cover Letter