Anonymous

Skills

Regulatory Affairs, Study Start-Up, ANMAT Regulations, Country Approval / Regulatory Submissions, Site Activation, Ethical Committee Submissions, Informed Consent Form (ICF) Localization, ICF Customization, Master ICF to Country-Level Adaptation, Site-Specific ICF Tailoring, Document Version Control, Local Regulatory Alignmen Clinical Trial Applications (CTA), Clinical Research Operations.
Critical Thinking, Regulatory Interpretation, Legal & Regulatory Analysis, Analytical Problem Solving, Risk Assessment, Priority Setting, Time Management & Prioritization, Milestone Tracking, High-Pressure Execution, Stakeholder Management, Effective & Assertive Communication, Attention to Detail, Adaptability & Resilience, Negotiation Skills.
ICH GCP, Clinical Data Surveillance, Central Monitoring / Risk-Based Monitoring (RBM), Key Risk Indicators (KRIs)
Clinical Trial Databases, Data Integrity & Quality Control, Source Data Verification (SDV), Site Management, Query Management.
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Clinical Data Science / Data Analytics. Artificial Intelligence in Clinical Research.
Legal & Regulatory Compliance
Cross-Functional Communication

About

Strategic, results-driven Senior Regulatory Affairs and Study Start-Up (SSU) Specialist with an ascending over 10-year career trajectory in clinical research (progressing from site-level coordination to global monitoring and regional regulatory strategy) and a total of 20 years in the healthcare sector. Expert in commanding the full end-to-end lifecycle of complex clinical trials,
including biologics and high-complexity therapies across LATAM (Argentina and Chile). Leverages a comprehensive, 360-degree understanding of clinical trial operations: built upon a foundational background as a Clinical Study Coordinator (mastering site-level execution, patient workflows, and investigator dynamics), advanced through an impactful tenure as a global Clinical Research Associate (CRA) (driving protocol compliance, sponsor communications, and flawless health authority audit defenses), and culminating in a Senior Regulatory & SSU leadership specialization. This unique progression enables the proactive identification of operational bottlenecks, seamless cross-functional matrix collaboration, and the absolute minimization of site-activation cycle times.
Noted for proactive leadership in accelerating the SSU critical path through matrixed cross-functional collaboration with global sponsors, clinical project managers, CRAs, and investigative sites. Recognized as a trusted mentor, formally assigned by management to coach and train colleagues on complex regulatory processes and trial execution. Holds an exceptional
record of 100% regulatory approval success and a robust reputation in Inspection Readiness, having successfully hosted, defended, and cleared 3 ANMAT audits and 1 FDA inspection with zero (0) regulatory findings, receiving formal institutional commendations for excellence in compliance. Equipped with deep technical knowledge of ANMAT Res. 7516/2025, CCIS
submissions, ReNIS database maintenance, and swift Import License extensions and other critical regulatory filings via the TAD platform, focused on ICH-GCP compliance and accelerating Site Green Light through efficient, systematic regulatory execution.
KEY REGULATORY ACHIEVEMENTS & METRICS
 100% Approval Success Rate: Secured 100% positive outcomes for all initial trial dossiers and substantial amendments submitted to ANMAT (Argentina) and ISP (Chile).
 Efficient SSU Timeline Acceleration: Consistently reduced site activation timelines, beating Sponsor deadlines by 1 week or 2–3 days ahead of schedule for submissions to Ethics Committees and Ministries of Health (MoH/ANMAT).
 Impeccable Inspection Excellence: Led the preparation and face-to-face defense of 3 ANMAT regulatory audits and 1 FDA inspection, achieving a flawless status of zero (0) regulatory findings.
 Portfolio Leadership: Strategically managed an expanded portfolio of up to 10 simultaneous clinical trials from startup through execution to database lock and formal closure.
 Record Site Activation: Directed the administrative and regulatory enablement (Site Green Light) of 17 clinical sites within a critical 6-week window.
Advance Core Competencies
 End-to-End Dossier Management: Systematic compilation, rigorous tracking, and lifecycle management of highcomplexity clinical trial dossiers, ensuring a consistent 100% health authority approval success rate across initial applications, Substantial Amendments, and Quality/CMC (Chemistry, Manufacturing, and Controls) Amendments.
 Multi-Jurisdictional Framework Mastery: Deep technical command of national frameworks (ANMAT Res. 7516/2025 in Argentina and ISP in Chile) seamlessly synchronized with decentralized Provincial Approval Instances, including full command of CCIS clearances and the PRIISA BA program registry workflows.
 SSU Critical Path Acceleration: Proven capacity to compress site-activation timelines and accelerate Site Green Light milestones through cross-functional risk mitigation, seamless Import/Export License extensions via TAD, and the strategic localization of Master ICFs while strictly satisfying individual Ethics Committee SOPs.
 Sanitary & Administrative Law Application: Leveraging an advanced legal background to interpret complex, shifting regulatory decrees, draft rock-solid administrative documentation, and enforce rigorous institutional compliance criteria.
 Unblemished Audit Defense: Flawless operational alignment with global ICH-GCP (E6(R2) / E6(R3) transition) guidelines, Ministry of Health (MoH) standards, and ALCOA+ data integrity principles; validated by a perfect historical record of hosting and clearing zero-finding regulatory audits (3 ANMAT and 1 FDA inspection).
 Pharmacovigilance & Safety Tracking: Rigorous oversight, meticulous compilation, and timeline-driven submission of periodic safety documentation, including Development Safety Update Reports (DSUR), Suspected Unexpected Serious Adverse Reactions (SUSAR), and mandatory Annual Progress Reports to Health Authorities and Ethics Committees
 Surgical ICF Control & IP Tracking: Elimination of site protocol deviation risks through systematic, multi-step version control and cross-checking between eTMF databases and Investigator Site Files (ISF), coupled with rigorous Investigational Product (IP reconciliation) and accountability tracking.
 Cross-Functional Stakeholder Alignment: Facilitating seamless, high-stakes communication channels between global Sponsors, Medical Project Leaders, regional CRAs, and multidisciplinary investigative site staff.
 Formal Team Mentorship: Formally assigned by executive management to coach, train, and onboard internal colleagues on complex regulatory platform execution, local submissions architecture, and operational standard operating procedures (SOPs).
 High-Intensity Field Execution: Capable of deploying rapid, high-velocity regional feasibility and site-selection campaigns across international territories under compressed timelines (e.g., executing 19 PSVs in a 1.5-month window).
 National Administrative Portals: ANMAT, ISP (Chile), TAD (Trámites a Distancia) Platform Expert (including Import/Export Licenses, First Patient Randomized - FPR notifications, and corresponding regulatory operational filings).
 Clinical Trial Databases & Systems: ReNIS Database architecture maintenance, Medidata Rave EDC, and interactive response technologies (IXRS/IRT).
 Document Governance Systems: Audit-ready eTMF / TMF (Trial Master File) archiving, indexing, and electronic quality control management under ALCOA+ standards