Manager of Regulatory Affairs, Consultant

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Manager of Regulatory Affairs, Consultant based in the United States.

Join a pioneering biopharmaceutical environment focused on developing innovative cell therapies for patients living with autoimmune diseases. In this six-month consulting engagement, you will contribute to the regulatory strategy and execution of clinical and nonclinical development programs. You will oversee key regulatory submissions, ensuring accuracy, quality, and compliance with applicable global requirements. Working closely with cross-functional teams, you will help align regulatory activities with scientific objectives and development timelines. You will also support interactions with health authorities, respond to regulatory inquiries, and contribute to inspection readiness. This role offers an opportunity to apply your regulatory expertise in a dynamic, research-driven environment at the forefront of cell therapy innovation. The ideal candidate combines strong technical knowledge, attention to detail, and a collaborative approach to advancing complex therapeutic programs.