Sr Manager, Regulatory Affairs

Gilead Sciences · Santa Monica, CA +1 more

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RegulatoryFull-time$143k–$185kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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