Sr Manager, Regulatory Affairs
$143.23k - $185.35kGilead
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
Vacancy posted 16 days ago
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