The Senior Manager/Associate Director will lead regulatory writing efforts across the development portfolio, planning and authoring high-quality documents from IND through marketing application. They will provide strategic leadership, manage document timelines, and ensure compliance with global regulatory standards while collaborating with cross-functional teams.
The Director of Global Regulatory Affairs leads the development and execution of regulatory strategies for assigned programs while serving as the primary regulatory representative on cross-functional teams. They are responsible for managing health authority interactions, overseeing major regulatory submissions, and providing strategic leadership throughout the product lifecycle.
Provide clinical development leadership and medical oversight for global programs focusing on rare musculoskeletal diseases. Lead cross-functional teams to execute clinical trials, author study protocols, and manage interactions with regulatory agencies and investigators.
