Job Summary

• The Director, Global Regulatory Leader will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area.
• Key responsibilities include leading the Global Regulatory Team, preparing company personnel for interactions with Health Authorities, and overseeing key health authority documents.
• The role offers a competitive base pay range of $164,000 to $282,900, eligibility for an annual performance bonus, and comprehensive benefits including medical, dental, vision, retirement plans, and various time-off benefits.

Matching Summary

Salary

Base: $164,000.00 - $282,900.00; Bonus/Equity: Eligible for annual performance bonus and long-term incentive program; Benefits: Medical, dental, vision, retirement plan, 401(k), vacation, sick time, holiday pay, parental leave, bereavement leave, caregiver leave, volunteer leave, military spouse time-off

Skills & Requirements

Key Requirements

• Bachelor's degree required
• 10+ years global health regulated industry experience
• Global regulatory experience with US FDA, EMA, and international regulations
• Knowledge of drug product lifecycle
• Understanding of FDA and ICH regulatory requirements
• Experience critically reviewing regulatory documents
• Ability to interpret and apply regulatory requirements

Work Rights