Senior Regulatory Start Up Associate - Bulgaria

The Senior Regulatory Start-Up Associate (Senior RSA) is responsible for the planning, preparation, coordination, and submission of country- and site-level ethics and regulatory authority applications during the start-up phase of clinical trials and, where applicable, throughout study maintenance and close-out. The role ensures all submissions comply with ICH-GCP guidelines, local regulatory requirements, and Novotech or client SOPs to support timely study activation.

The Senior RSA is a fully competent regulatory professional who works with a high degree of autonomy while managing multiple studies and competing priorities. The role also supports continuous process improvement, mentors junior team members, and serves as a subject matter expert on local regulatory requirements and start-up activities.