Novotech is seeking a Senior Regulatory Start Up Associate in Australia to plan, prepare and review ethics and regulatory submissions during trial start-up and, where applicable, maintenance and close-out. You will ensure compliance with ICH-GCP guidelines and local regulatory requirements to support timely approvals.
You will support RSA training, mentor junior RSAs, and act as the local subject matter expert on regulatory start-up activities, collaborating with cross-functional teams to