Senior Regulatory Start Up Associate - NSW
Core
Planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials.
Role type
Senior Regulatory Start-Up Associate
Builds
Regulatory submissions for clinical trial approvals
Domain
Clinical trials / Life sciences
Required skills
Regulatory submission planning, ICH-GCP compliance, stakeholder balancing, process improvement, training delivery, subject matter expertise
Responsibilities
Develop master and country ICFs, study specific forms, and documents for Central EC/IRB, local EC/Governance, and Regulatory Authority applications; Participate in company start-up initiatives to develop and maintain Regulatory Start Up processes, tools, and SOPs; Assist with RSA training in development and delivery of training; Serve as the local subject matter expert on specialized aspects of regulatory and start-up activities
Seniority
Senior, hands-on IC
