Regulatory Start Up Associate II - AU

Description The Regulatory Start-Up Associate II (RSA), are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials, and, where applicable, throughout maintenance and close-out. They ensure that all submissions comply with ICH-GCP guidelines and local regulatory requirements to support timely trial approvals. The RSA II has an action-oriented mindset to proactively address challenge…