Theradex Oncology

The Regulatory Affairs Manager will manage the preparation and submission of European Clinical Trial Applications and amendments while serving as a key regulatory liaison. They will also provide strategic cross-functional support for regulatory development and ensure compliance with EU clinical trial regulations.

Provide strategic regulatory input and manage the preparation and submission of European Clinical Trial Applications and Master Core Dossiers. Act as the key regulatory liaison for multi-continental oncology projects and support business development activities.

The role involves leading the end-to-end delivery of IT projects, balancing technical analysis (60%) and project management (40%). Key duties include defining project scope, analyzing business requirements, and performing detailed data reviews to build innovative IT solutions.

The Senior Medical Writer is responsible for preparing critical regulatory documents including IND applications, clinical study protocols, and investigator's brochures for oncology trials. The role involves collaborating directly with clients, medical monitors, and senior leadership to manage document timelines and review cycles.