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Sr Director, Regulatory Affairs

Rezolutebio
Location
Redwood City
Posted
1 month ago
Department
Regulatory Affairs
What they actually want (must-haves)
  • Deep expertise in rare disease regulatory pathways
  • Experience in biologics development
  • Strong understanding of CMC considerations for biologics
  • Experience with BLA submissions
  • Experience in late-stage approval activities
  • Experience supporting commercial launch
What the job really is

The Sr Director of Regulatory Affairs at Rezolute will lead regulatory efforts for late-stage clinical development, focusing on FDA interactions and U.S. registration. This role involves strategic and operational leadership, supporting regulatory submissions and product launches, particularly for therapies addressing rare diseases. The candidate will work closely with project teams to implement regulatory strategies and navigate complex requirements for biologics development.

Benefits
  • Health Insurance (Medical / Dental / Vision)
  • Disability, Life & Long-Term Care Insurance
  • Holiday Pay
  • Tracking Free Vacation Program
  • 401(k) Plan Match
  • Educational Assistance Benefit
Things to weigh
  • Fast-paced environment may require adaptability
  • Role involves both strategic vision and execution, which may be demanding
Job score3.2/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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