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Precision for Medicine is expanding regulatory and clinical trial operations across Latin America (Mexico, Brazil, Argentina, Colombia, Chile, and Peru). This Senior Regulatory and Site Start-Up Specialist role is based in Brazil and serves as the first in-country regulatory expert for the region.
You will lead regulatory submissions and site activation activities for clinical trials, managing interactions with Competent Authorities, Ethics Committees, and local regulatory bodies. Key responsibilities include preparing and submitting clinical trial applications and dossiers (initial and amendments), handling regulatory correspondence, and ensuring timely approvals per ICH-GCP standards and local regulations.
As a subject matter expert, you will guide less-experienced staff on site start-up compliance, develop country-specific tools and guidance documents, and maintain regulatory intelligence. You'll coordinate essential document collection and quality review, customize patient information sheets and informed consent forms for local requirements, and manage translation coordination for submission documents.
You will partner closely with Clinical Research Associates, Site Contract Management, and Project Management teams to ensure site activation readiness, manage critical path timelines for Competent Authority and Ethics Committee approvals, and support budget and contract negotiations. You'll maintain audit/inspection readiness, keep current with evolving local clinical trial laws and regulations, and disseminate regulatory knowledge across the organization to ensure compliant trial conduct.
