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Senior Manager Regulatory Affairs

Trebla Talent

Role Senior Manager/ AD, Regulatory Strategy Location Bay Area (Hybrid) About the Organization Our client is a well‑funded, pre‑IPO clinical‑stage biotechnology company focused on developing innovative therapies for patients with cancer and other serious diseases. Role Description This strategist will support the company's lead program through late‑stage development and play a key role in preparing for BLA submission. Key Responsibilities Lead global regulatory strategy for late‑stage development programs, including Phase 3 assets and pre‑BLA activities Prepare for health authority milestone meetings Own CSR planning and oversee collaborations Lead the development of PSP Qualifications Bachelor's degree in a scientific discipline; advanced degree preferred. 10+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry. Significant experience developing and executing global regulatory strategy for late‑stage oncology programs. Demonstrated success in leading or planning BLA submissions Strong executive presence, communication skills, and scientific acumen. Remote candidates will also be considered. #J-18808-Ljbffr

Vacancy posted 7 hours ago
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