The Associate Director of Regulatory Affairs develops and executes regulatory strategies, manages submissions, collaborates with teams, and interacts with regulatory agencies to support organ transplantation programs.

Lead day-to-day management of clinical studies, vendors, CROs, timelines, and budgets. Prepare and review study documents, maintain trial master file, ensure GCP/SOP compliance, coordinate audits, communicate status to stakeholders, and identify/mitigate study risks.