Sr Manager, Regulatory Affairs

Senior Manager of Regulatory Affairs at Kite responsible for developing regulatory strategies, leading submissions to health authorities (FDA, EMA, others), and managing cross-functional teams for oncology drug development programs. Based in California with flexible work policy.

Responsibilities

• Develop and implement regulatory product strategies for assigned programs
• Serve as US Regulatory Lead for teams developing regulatory strategies and executing filings
• Plan, prepare, and review submissions to FDA, EMA, and other authorities for IND, CTA, BLA, MAA
• Monitor regulatory intelligence and disseminate information affecting development programs
• Train, manage, and mentor regulatory affairs personnel

Requirements

• Bachelor's degree with 8+ years regulatory experience, or Master's degree with 6+ years
• Experience leading regulatory submissions and managing regulatory projects
• Experience writing or updating regulatory processes
• Experience working within project teams
• Advanced degree (MS, PhD, or PharmD) in scientific discipline preferred
• Knowledge of global regulatory requirements and guidelines
• Experience preparing/submitting regulatory documents and leading health authority interactions

Compensation: Other US Locations: $143,225–$185,350; Bay Area: $157,590–$203,940