Actithera
1 - 10 employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
💰 $75.5M Series A - Actithera on 2025-07
Healthcare • Biotechnology • Pharmaceuticals
Actithera is a biotechnology company developing next-generation radioligand therapies (RLTs) for cancer. The company designs molecules that link radioactive isotopes to small molecules and modified peptides to deliver targeted, sustained radiation to tumors while sparing healthy tissues. Actithera is a discovery-stage firm with assets in IND-enabling studies and aims to enable effective, better-tolerated, personalized cancer treatments with fewer therapy cycles through proprietary chemistry that matches radionuclide half-lives to tumor residence time.
Global Regulatory Head
Job not on LinkedIn
🔥 13 minutes ago
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Actithera
1 - 10 employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
💰 $75.5M Series A - Actithera on 2025-07
Healthcare • Biotechnology • Pharmaceuticals
Actithera is a biotechnology company developing next-generation radioligand therapies (RLTs) for cancer. The company designs molecules that link radioactive isotopes to small molecules and modified peptides to deliver targeted, sustained radiation to tumors while sparing healthy tissues. Actithera is a discovery-stage firm with assets in IND-enabling studies and aims to enable effective, better-tolerated, personalized cancer treatments with fewer therapy cycles through proprietary chemistry that matches radionuclide half-lives to tumor residence time.
📋 Description
• Direct the regulatory strategy and submissions for the company's radioligand therapy (RLT) portfolio • Own and compile briefing books for FDA Type B/C meetings and EMA scientific advice • Lead preparation, submission, and maintenance of INDs, CTAs, and amendments • Formulate global regulatory strategies, including accelerated pathways for oncology RLT assets • Represent the company in interactions with FDA, EMA, PMDA, and other health authorities • Prepare responses to health authority queries on RLT topics • Ensure submissions comply with ICH, GMP, and radiation-specific regulations • Collaborate with clinical, CMC, and quality teams on regulatory requirements • Monitor regulatory landscapes for RLT advancements and update strategies • Mentor regulatory staff and build capabilities in RLT submissions
🎯 Requirements
• Bachelor's or advanced degree in regulatory science, pharmacy, or related field • 10+ years in regulatory affairs • 5+ years in leadership • Experience focused on biologics or radiopharmaceuticals • Proven success in IND/CTA filings and interactions with global health authorities • In-depth knowledge of RLT regulations, including dosimetry reporting and orphan drug pathways • Strong writing and strategic thinking skills • Experience in high-stakes negotiations • Knowledge of ICH, GMP, and radiation-specific regulations, including 21 CFR Part 212 for PET drugs
🏖️ Benefits
• Annual bonus eligibility • Equity participation • Comprehensive benefits program • Market-based, results-driven compensation
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