Celcuity
51 - 200 employees
🧬 Biotechnology
💊 Pharmaceuticals
🔥 Funding within the last year
💰 $500M Post-IPO Debt - Celcuity on 2025-09
Biotechnology • Pharmaceuticals
Celcuity is a clinical-stage biotechnology company developing targeted therapies that comprehensively block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead product candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor in late-stage clinical development (including Phase 3 VIKTORIA trials) for HR+/HER2- advanced breast cancer and other indications such as prostate cancer. The company advances a focused pipeline of PAM pathway inhibitors, publishes clinical data, engages with investors and regulators, and is mission-driven to improve outcomes for cancer patients.
Executive Director, Regulatory Affairs – Global
🕒 May 15
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Celcuity
51 - 200 employees
🧬 Biotechnology
💊 Pharmaceuticals
🔥 Funding within the last year
💰 $500M Post-IPO Debt - Celcuity on 2025-09
Biotechnology • Pharmaceuticals
Celcuity is a clinical-stage biotechnology company developing targeted therapies that comprehensively block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead product candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor in late-stage clinical development (including Phase 3 VIKTORIA trials) for HR+/HER2- advanced breast cancer and other indications such as prostate cancer. The company advances a focused pipeline of PAM pathway inhibitors, publishes clinical data, engages with investors and regulators, and is mission-driven to improve outcomes for cancer patients.
📋 Description
• lead and participate in global regulatory activities • develop innovative global regulatory strategies • provide strategic regulatory guidance for global development • coordinate with internal and external stakeholders • mentor junior staff • oversee regulatory activities and submissions • ensure compliance with global regulatory requirements
🎯 Requirements
• BS/ MS/ PhD in a relevant scientific discipline • minimum of 15 years in the biopharmaceutical industry • 10+ years of experience in pharmaceutical or biotech regulatory affairs • experience in clinical regulatory affairs for oncology products • ability to translate regulatory requirements into practical workable plans • diverse experience with regulatory activities • strong organizational skills • effective interpersonal and communication skills • demonstrated ability to achieve high performance goals in a fast-paced environment
🏖️ Benefits
• annual performance incentive bonus • new hire equity package • medical insurance • dental insurance • vision insurance • 401(k) match • PTO • paid holidays
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