Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy

Zse68

Base: $218,058.40 - 327,087.60; bonus/equity: not ...
Hybrid (3 days in the office)
Global regulatory strategy development
Experience in cell and gene therapy
Leadership in regulatory submissions
The Senior Regulatory Affairs Director for Oncology Cell and Gene Therapy at Zse68 is responsible for leading the global regulatory strategy for complex CGT products, ensuring efficient approval and competitive labeling. The role requires extensive experience in regulatory affairs, particularly within oncology and cell/gene therapy, while fostering a culture of collaboration and mentorship within the team. ###

Job Summary

  • The Senior Director will lead the global regulatory strategy for complex CGT products.
  • This role offers the opportunity to influence strategy from early development through global approvals.
  • A competitive salary and benefits package is available, promoting work-life balance and collaboration.

Matching Summary

Match Score: 85

The Senior Regulatory Affairs Director for Oncology Cell and Gene Therapy at Zse68 is responsible for leading the global regulatory strategy for complex CGT products, ensuring efficient approval and competitive labeling. The role requires extensive experience in regulatory affairs, particularly within oncology and cell/gene therapy, while fostering a culture of collaboration and mentorship within the team. ###

Salary

Base: $218,058.40 - 327,087.60; Bonus/Equity: Not specified; Benefits: Health benefits including medical, dental, and vision coverage

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • Experience in cell and gene therapy
  • Leadership in regulatory submissions

Nice-to-have

  • Experience with FDA advisory committee
  • Strong organizational and presentation skills
  • Ability to manage multiple projects

Key Requirements

  • Advanced degree in a science related field
  • Seven to ten years of relevant experience
  • Experience with multiple myeloma product development

Work Rights

Not specified

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