Senior Regulatory Affairs Leader - Hybrid/Remote

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

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Benefits package

Job summary

Kite Pharma is seeking a Senior Regulatory Affairs Leader to guide global regulatory strategies for oncology programs in Santa Monica and potential relocation considerations. You will lead cross-functional teams, drive submissions to FDA/EMA, and ensure compliance across lifecycle stages.

The role requires extensive experience with regulatory submissions, strong leadership, and the ability to mentor others while navigating complex guidelines and timelines.

Qualifications

• BA/BS with 8+ years’ relevant experience.
• MA/MS/MBA with 6+ years’ relevant experience.
• Experience leading regulatory submissions and other regulatory projects is strongly preferred.

Responsibilities

• Develop regulatory product strategies and ensure alignment with cross-functional teams.
• Represent regulatory on cross-functional development teams and manage timelines.
• Plan, prepare and review submissions to FDA/EMA and other authorities.
• Lead and mentor regulatory personnel and coordinate with authorities for meetings.

Skills

Regulatory strategy

Leadership

Regulatory submissions

Project management

Risk assessment

Regulatory affairs

Education

BA/BS & 8+ years

MA/MS/MBA & 6+ years

Job description

Kite Pharma is seeking a Senior Regulatory Affairs Leader to guide global regulatory strategies for oncology programs in Santa Monica and potential relocation considerations. You will lead cross-functional teams, drive submissions to FDA/EMA, and ensure compliance across lifecycle stages.

The role requires extensive experience with regulatory submissions, strong leadership, and the ability to mentor others while navigating complex guidelines and timelines.