Director, Global Regulatory Leader

Johnson & Johnson MedTech

Raritan, New Jersey, United States of America
Base: $164,000.00 - $282,900.00; bonus/equity: eli...
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.
  • Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed, leading and/or participating in meetings with regulatory agencies.
  • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)) and are eligible for various time off benefits.

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

Base: $164,000.00 - $282,900.00; Bonus/Equity: Eligible for annual performance bonus and long-term incentive program; Benefits: Medical, dental, vision, life insurance, disability, retirement plan, 401(k), paid time off

Skills & Requirements

Must-have

  • Global regulatory strategies
  • Rare disease and advanced cell therapy
  • Immunology Therapeutic Area
  • Cross-functional team leadership
  • Health Authority interactions
  • Submission document review

Nice-to-have

  • Strategic regulatory advice
  • Competitive landscape understanding
  • Collaborative team environment
  • Independent judgment and execution

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 requirements
  • Experience reviewing/compiling regulatory documents
  • Ability to interpret regulatory requirements

Work Rights

Not specified

Tailored Resume

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