Senior Regulatory Affairs Leader – US Submissions

Kite Pharma, Inc.; Santa Monica (CA); Hybrid; USD 143,000 - 185,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Discretionary bonus

Stock-based incentives

Paid time off

Job summary

Kite Pharma, Inc. seeks a Senior Manager, Regulatory Affairs to lead regulatory strategy and submissions for late-stage cancer therapies. The role involves coordinating with cross-functional teams, preparing regulatory documents, and interacting with US and global authorities.

The position supports relocation planning as Kite transitions headquarters and offers a flexible hybrid work policy. The candidate will mentor staff, manage timelines, and ensure compliance with FDA/EMA guidelines across

Qualifications

• BA/BS in science or related field required or equivalent
• MS/PhD/PharmD preferred for advanced regulatory work
• Experience leading regulatory submissions and cross-functional teams

Responsibilities

• Develop and implement regulatory product strategies
• Represent regulatory on cross-functional development teams
• Prepare and review regulatory submissions (FDA/EMA/etc.)
• Lead and mentor regulatory personnel on project teams
• Coordinate interactions with regulatory authorities and meetings

Skills

Regulatory affairs leadership

Regulatory submissions

Cross-functional collaboration

Project management

Attention to detail

Education

BA/BS in science or related field

MS/PhD/PharmD (preferred)

Job description

Kite Pharma, Inc. seeks a Senior Manager, Regulatory Affairs to lead regulatory strategy and submissions for late-stage cancer therapies. The role involves coordinating with cross-functional teams, preparing regulatory documents, and interacting with US and global authorities.

The position supports relocation planning as Kite transitions headquarters and offers a flexible hybrid work policy. The candidate will mentor staff, manage timelines, and ensure compliance with FDA/EMA guidelines across