Director, Global Regulatory Leader

Johnson & Johnson Innovative Medicine

Raritan, New Jersey, United States of America
$164,000.00 - $282,900.00; annual performance bonu...
Hybrid
Global regulatory strategies
Rare disease and advanced cell therapy
Immunology therapeutic area
Develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area

Job Summary

  • Develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area.
  • Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization.
  • Employees and/or eligible dependents may be eligible to participate in various Company sponsored employee benefit programs including medical, dental, vision, and retirement plans.

Matching Summary

Develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area.

Salary

$164,000.00 - $282,900.00; Annual performance bonus; Medical, dental, vision, retirement plans

Skills & Requirements

Must-have

  • Global regulatory strategies
  • Rare disease and advanced cell therapy
  • Immunology Therapeutic Area
  • Health Authority interactions
  • Submission and approval process

Nice-to-have

  • Shaping global regulatory strategies
  • Independent judgment and execution
  • Collaborative team environment

Key Requirements

  • Bachelor's degree required
  • 10+ years global health regulated industry
  • Global regulatory experience with US FDA, EMA
  • Knowledge of drug product lifecycle
  • Understanding of ICH guidelines
  • Experience reviewing regulatory documents

Work Rights

Not specified

Tailored Resume

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