Associate I/II, Regulatory Operations

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

The Associate I/II, Regulatory Operations will provide essential regulatory operations and document management support across Capricor’s development and potential commercial programs. This role is primarily responsible for tracking regulatory deliverables, maintaining document repositories and archives, and assisting with submission readiness, publishing, and lifecycle management activities. The Associate will collaborate closely with Regulatory Affairs, CMC, Clinical, Quality, Manufacturing, and other cross-functional teams to ensure regulatory documents are complete, accurate, current, and readily available to support BLA submissions, regulatory interactions, and ongoing compliance in a fast-paced biotech environment.