Sioux Falls, SD6 days ago
The ideal candidate will bring extensive experience supporting late-phase biologics programs within agile biotech environments, with a demonstrated ability to drive submission readiness, support commercial launch planning, and partner cross-functionally to advance programs through regulatory approval and commercialization. This role requires deep expertise in biologics regulatory writing, including leadership of Biologics License Applications (BLA), Marketing Authorization Applications (MAA), clinical study reports (CSRs), and global regulatory submissions to the FDA, EMA, and other international health authorities.