Director, Global Regulatory Leader

J&J FAMILY OF COMPANIES

Raritan, New Jersey, United States of America
Base: $164,000 to $282,900; bonus/equity: annual p...
**
Global regulatory strategy development
Regulatory submission and approval process
Leadership of cross-functional teams
** Johnson & Johnson is seeking a Director, Global Regulatory Leader to spearhead global regulatory strategies for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area. The role is hybrid and requires significant experience in regulatory affairs, along with strong leadership and communication skills. The position offers competitive salary and benefits, emphasizing a collaborative and inclusive work environment. **

Job Summary

  • Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through innovative medicine and MedTech solutions.
  • The Director, Global Regulatory Leader will lead global regulatory strategies and serve as the key regulatory contact to support successful development and commercialization of advanced therapies.
  • The position offers competitive compensation, comprehensive benefits, and opportunities for remote work within the United States.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Director, Global Regulatory Leader to spearhead global regulatory strategies for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area. The role is hybrid and requires significant experience in regulatory affairs, along with strong leadership and communication skills. The position offers competitive salary and benefits, emphasizing a collaborative and inclusive work environment. **

Salary

Base: $164,000 to $282,900; Bonus/Equity: Annual performance bonus at company discretion; Benefits: Medical, dental, vision, life insurance, disability, retirement plans, paid time off

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • Regulatory submission and approval process
  • Leadership of cross-functional teams
  • Health Authority interactions
  • Regulatory compliance management
  • Knowledge of FDA and EMA regulations

Nice-to-have

  • Experience with Immunology and Oncology areas
  • Knowledge of advanced therapies like CAR-T
  • Strong oral and written communication skills
  • Ability to prioritize multiple projects
  • Collaborative team environment experience
  • Strategic regulatory advice

Key Requirements

  • Bachelor’s degree in scientific or technical discipline
  • Minimum 10 years global health regulated industry experience
  • Advanced degree preferred (Master’s, PharmD, or PhD)
  • Deep expertise in U.S. FDA, EMA, and international regulations
  • Experience with drug product lifecycle and regulatory submissions
  • Ability to interpret and apply regulatory requirements
  • Up to 10% domestic and international travel

Work Rights

Not specified

Tailored Resume

Cover Letter