Senior Regulatory Affairs Manager: Global Submissions

Kite Pharma; Foster City (CA); Hybrid; USD 158,000 - 204,000; Full time

Benefits offered by this job

Discretionary annual bonus

Discretionary stock-based long-term IN

Paid time off

Benefits package

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

Kite Pharma is seeking a senior Regulatory affairs leader to shape regulatory strategies and drive submissions for multi-therapeutic programs in the US. You will guide cross-functional teams, manage risks, and ensure timely regulatory filings across FDA and EMA pathways.

The role involves mentoring others, coordinating with authorities, and contributing to a dynamic portfolio within a leading biopharmaceutical company focused on cancer immunotherapies.

Qualifications

• BA/BS with 8+ years’ regulatory experience or MA/MS with 6+ years’ regulatory experience.
• Experience leading regulatory submissions and other regulatory projects is strongly preferred.
• Experience writing or updating processes and working in project teams.
• Experience with one or more Gilead therapeutic areas and varying stages of drug development is preferred.

Responsibilities

• Develop and implement regulatory product strategies.
• Represent the regulatory function on cross-functional development teams.
• Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies.
• Plan, prepare, and review submissions to authorities such as FDA and EMA to support clinical trials and marketing applications.
• Lead and oversee activities for assigned projects to ensure compliance with FDA requirements.
• Coordinate and prepare responses to information requests from regulatory authorities.
• Train, manage, and mentor regulatory affairs personnel.

Skills

Regulatory strategy

FDA/EMA submissions

Cross-functional leadership

Regulatory guidance

Risk assessment

Project management

Stakeholder communication

Education

BA/BS with 8+ years’ relevant experience

MA/MS/MBA with 6+ years’ relevant experience

Job description

Kite Pharma is seeking a senior Regulatory affairs leader to shape regulatory strategies and drive submissions for multi-therapeutic programs in the US. You will guide cross-functional teams, manage risks, and ensure timely regulatory filings across FDA and EMA pathways.

The role involves mentoring others, coordinating with authorities, and contributing to a dynamic portfolio within a leading biopharmaceutical company focused on cancer immunotherapies.