Actithera

Compliance

• 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

Global Regulatory Head

Head of Department

• Author and revise the Investigator Brochure (IB), synthesizing data with a focus on RLT aspects.
• Create and oversee Statistical Analysis Plans (SAPs) for clinical trials.
• Lead the writing of Clinical Study Reports (CSRs), integrating trial results and safety narratives.
• Compile and author summaries of nonclinical data for regulatory documents.
• Design and produce scientific figures and visuals for reports and presentations.
• Analyze clinical trial data to inform decisions and support team collaboration.
• Guide clinical scientists on best practices for document writing and workflows.

Global Regulatory Head

Head of Clinical Affairs