Senior Regulatory and Start Up Specialist (Argentina)
Core
Senior Regulatory and Start Up Specialist responsible for clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review, Essential Document collection, and supporting site contract management in Argentina.
Role type
Senior IC regulatory and site start-up specialist
Builds
Clinical trial authorizations and site activation readiness for Argentina
Domain
Clinical trials / Life sciences
Required skills
Clinical trial submission, IRB/EC interaction, Informed Consent Form adaptation, Essential Document collection, Contract negotiation support, Regulatory intelligence, Project planning, Translation coordination, Feasibility assessment, Training and mentoring
Preferred skills
Country-specific regulatory experience, Milestone tracking tools, Problem resolution for junior staff, Advanced degree (MD/PhD/PharmD), RAC certification, Masters in Regulatory Science
Technologies
Computerized information systems, Electronic spreadsheets, Word processing, Electronic mail, Milestone tracking tools
Responsibilities
Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees; Interact with CA/EC for study purposes; Maintain project plans and regulatory intelligence tools; Customize Patient Information Sheets and Informed Consent Forms; Coordinate document translations; Partner with site CRAs for alignment; Support budget and investigator contract negotiations; Maintain audit/inspection readiness; Support Pre-Study Site Visits and feasibility outreach; Develop country-specific start-up summaries and process flows; Mentor staff on local regulations.
Seniority
Senior, hands-on IC
