Regulatory Affairs Director

Trzdev35

Gaithersburg, MD, United States
Base: $178,534.40 - 267,801.60 usd; bonus/equity: ...
Hybrid
Strategic regulatory leadership
Experience with cell and gene therapy
Major health authority interactions
The Regulatory Affairs Director provides strategic and operational regulatory leadership for cell and gene therapy products

Job Summary

  • The Regulatory Affairs Director provides strategic and operational regulatory leadership for cell and gene therapy products.
  • You will lead cross-functional teams in major regulatory submissions and health authority interactions.
  • The position offers a hybrid work environment and competitive compensation with various benefits.

Matching Summary

The Regulatory Affairs Director provides strategic and operational regulatory leadership for cell and gene therapy products.

Salary

Base: $178,534.40 - 267,801.60 USD; Bonus/Equity: Not specified; Benefits: Health, dental, and vision coverage

Skills & Requirements

Must-have

  • Strategic regulatory leadership
  • Experience with cell and gene therapy
  • Major Health Authority interactions

Nice-to-have

  • Scientific background in oncology
  • Understanding of CMC regulatory principles
  • Critical thinking on global regulatory science

Key Requirements

  • Bachelor's degree in a science-related field
  • At least 5 years of regulatory drug development experience
  • Hands-on leadership of IND and pre-IND CGT programs

Work Rights

Not specified

Tailored Resume

Cover Letter