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.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Matching Summary

Salary

$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

Key Requirements

• Minimum Bachelor's degree
• 10+ years global health regulated industry
• Global regulatory experience
• Deep expertise in U.S. FDA, EMA, and international regulations
• Knowledge of drug product lifecycle
• Understanding of ICH regulatory requirements
• Experience critically reviewing regulatory documents

Work Rights