Actithera

• 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