Actithera
1 - 10 employees
🧬 Biotechnology
đź’Š Pharmaceuticals
đź’° $75.5M Series A - Actithera on 2025-07
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
đź•’ March 18
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Actithera
1 - 10 employees
🧬 Biotechnology
đź’Š Pharmaceuticals
đź’° $75.5M Series A - Actithera on 2025-07
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.
đź“‹ Description
• Author and compile briefing books for regulatory meetings • Lead the preparation, submission, and maintenance of INDs, CTAs, and amendments • Formulate global regulatory strategies, including accelerated pathways for RLT assets • Represent the company in interactions with FDA, EMA, PMDA, and other agencies • Ensure all submissions comply with ICH, GMP, and radiation-specific regulations • Collaborate with clinical, CMC, and quality teams to align on regulatory requirements • Monitor regulatory landscapes for RLT advancements and update strategies accordingly • 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, with 5+ years in leadership, focused on biologics or radiopharmaceuticals • Proven success in IND/CTA filings and interactions with global authorities • In-depth knowledge of RLT regulations, including dosimetry reporting and orphan drug pathways • Strong writing and strategic thinking skills, with experience in high-stakes negotiations.
🏖️ Benefits
• Annual bonus • Equity participation • Comprehensive benefits program
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