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.

The Lead Clinical Research Associate leads site monitoring activities, oversees CRAs, ensures compliance with protocols and regulations, and develops monitoring tools for clinical trials.

The Senior Clinical Research Associate will manage clinical trial sites, ensure protocol compliance, data integrity, and oversee monitoring visits. Responsibilities include training site personnel, supporting patient recruitment, and ensuring inspection readiness.

The QA Manager oversees GMP production operations, ensuring compliance with regulations and quality standards in manufacturing drug products.