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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 Argentina and serves as the first in-country regulatory expert for the region.
You will lead all regulatory and site activation activities for clinical trials in Argentina, acting as a subject matter expert and trainer for less-experienced staff. Key responsibilities include preparing and submitting clinical trial applications to Competent Authorities and Ethics Committees, managing regulatory interactions and responses, customizing Informed Consent Forms and Patient Information Sheets for local requirements, and coordinating essential document collection and quality review.
You will own country-specific tools, guidance documents, and regulatory intelligence to ensure compliance with local and international clinical trial regulations (ICH-GCP principles). You'll partner closely with Clinical Research Associates, Site Contract Management, Project Management, and Clinical Operations teams to ensure timely and compliant site activation. Additional duties include managing translations of regulatory documents, maintaining audit/inspection readiness, maintaining project trackers and regulatory timelines, and supporting budget and contract negotiations with investigator sites.
This is a strategic role requiring deep expertise in Latin American regulatory pathways, clinical trial law, and site activation best practices. You will be the go-to regulatory authority for your country and help distribute regulatory knowledge across the broader Precision for Medicine organization.
