Director, Global Regulatory Leader

J&J FAMILY OF COMPANIES

Raritan, New Jersey, United States of America
Base: $164,000 to $282,900 (us locations); bonus: ...
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10 years global health regulated industry experience
Deep expertise in fda ema international regulations
Drug product lifecycle knowledge from discovery to marketing
** Johnson & Johnson is seeking a Director, Global Regulatory Leader to implement regulatory strategies for investigational rare disease and advanced cell therapy products in the Immunology Therapeutic Area. The role requires extensive global regulatory experience and offers a hybrid working model with competitive compensation and benefits. **

Job Summary

  • The Director, Global Regulatory Leader will develop and implement integrated regulatory strategies for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area.
  • This role requires leading cross-functional teams, managing key health authority documents, and negotiating post-approval commitments while ensuring compliance with global regulatory requirements.
  • Johnson & Johnson offers a competitive compensation package including an annual performance bonus, comprehensive medical and dental benefits, and up to 120 hours of vacation time per calendar year.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Director, Global Regulatory Leader to implement regulatory strategies for investigational rare disease and advanced cell therapy products in the Immunology Therapeutic Area. The role requires extensive global regulatory experience and offers a hybrid working model with competitive compensation and benefits. **

Salary

Base: $164,000 to $282,900 (US locations); Bonus: Eligible for annual performance-based cash bonus; Benefits: Medical, dental, vision, 401(k), up to 120 hours vacation

Skills & Requirements

Must-have

  • 10 years global health regulated industry experience
  • Deep expertise in FDA EMA international regulations
  • Drug product lifecycle knowledge from discovery to marketing
  • Critical review of regulatory submission documents
  • Leading interactions with Health Authorities

Nice-to-have

  • Knowledge of Immunology and Oncology therapeutic areas
  • Experience with advanced therapies like CAR-T
  • Strong collaborative team environment skills
  • Ability to prioritize multiple products simultaneously
  • Excellent oral and written communication skills

Key Requirements

  • Minimum Bachelor's degree required; Master's/PharmD/PhD preferred
  • Minimum 10 years of global health regulated industry experience
  • Understanding of FDA and ICH regulatory guidelines
  • Proven track record in shaping global regulatory strategies
  • Must have excellent oral and written communication skills

Work Rights

Not specified

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