• Support the Director in coordinating and implementing study startup activities in collaboration with CROs and internal study teams. • Assist in identifying country-specific regulatory and ethics committee requirements to facilitate timely CTA approvals. • Review and prepare submission packages for Regulatory Authorities and IRB/IEC for completeness and accuracy. • Ensure required Quality documentation (e.g., QP declaration, GMP Certification) is available for drug release. • Track and coordinate responses to Regulatory and IRB/IEC queries and deficiency letters with subject matter experts. • Monitor and report on CTA status updates and study startup progress across assigned projects. • Maintain internal regulatory files and ensure documentation is complete and accessible. • Support the review and maintenance of the Trial Master File for regulatory and ethics committee documentation. • Update global clinical trial registries (e.g., ClinicalTrials.gov) as required. • Participate in Study Management Team meetings to represent regulatory/study startup perspectives. • Assist in gathering and sharing regulatory intelligence related to study startup. • Contribute to the development and maintenance of SOPs and process improvement initiatives. • Support strategic planning and risk mitigation efforts related to study startup activities. • Travel up to 10% for team meetings and company events.