PAHO Consultant - Sistema regulatorio nacional mediante la Herramienta Mundial de Evaluación (GBT)

Organizational Context

The Pan American Health Organization (PAHO) serves as the Regional Office for the Americas of the World Health Organization (WHO).

Job Purpose

To provide technical assistance to the National Administration of Medicines, Food and Medical Technology (ANMAT) in Argentina for the evaluation of its national regulatory system using the Global Benchmarking Tool (GBT). This involves supporting strategic organization for self-assessment and formal evaluation, assisting with comparative self-assessment, preparing technical narratives and supporting documentation, aiding in the formulation or update of the Institutional Development Plan (PDI), and preparing for the formal benchmarking evaluation.

Responsibilities

Conduct technical reviews of ANMAT's current status against GBT requirements, identifying priorities, internal organizational gaps, and documentation needs. Support ANMAT in designing an internal work plan and structure for self-assessment, including responsibility allocation and a realistic timeline. Develop a detailed roadmap for the formal evaluation process with milestones, deadlines, and responsible parties. Accompany ANMAT technical teams in their GBT self-assessment, ensuring proposed ratings are evidence-based and consistent with GBT criteria. Guide teams on appropriate evidence types and support their systematic organization. Identify documentation or implementation gaps and propose concrete recommendations. Review the coherence of proposed ratings, justifications, and supporting documentation. Support the drafting of clear technical narratives and the preparation of organized supporting documentation. Assist in preparing ANMAT's institutional presentation on its regulatory system. Support the formulation or update of ANMAT's PDI based on identified gaps, ensuring a gradual and prioritized approach. Facilitate logistical and technical arrangements for the formal benchmarking evaluation and prepare ANMAT teams for interviews with the evaluation team. Prepare periodic technical progress reports, identify risks, and propose adjustments. Participate in technical field missions as needed. Fulfill other technical tasks assigned by supervision.

Work Experience

Minimum 20 years of relevant experience in the regulation of medicines or other health technologies, with demonstrated experience in the functions of a national regulatory authority. Direct and demonstrated experience in at least two of the regulatory functions covered by the GBT (registration and marketing authorization, pharmacovigilance, regulatory inspection, market control, licensing, laboratory testing, or clinical trial oversight). Profound and demonstrated knowledge of the Global Benchmarking Tool (GBT) methodology, including its indicator structure, rating system, regulatory maturity levels, and PDI development. Experience in regulatory system self-assessment processes, institutional benchmarking, or preparation for external evaluations, preferably within the GBT context or similar evaluation tools. Direct experience in evaluating reference regulatory authorities (at least 3). Experience leading institutional recognition processes as a reference regulatory authority. Experience in developing technical regulatory documentation (procedures, institutional narratives, technical reports). Experience in regional technical cooperation or coordination with international organizations in the regulatory field is desirable. Knowledge of the Argentine regulatory system (ANMAT) and national health technology regulations is desirable.

Skills

Ability to translate complex methodological frameworks into practical and applicable guidance for regulatory technical teams. Excellent technical writing and institutional communication skills. Aptitude for working with multiple institutional stakeholders and managing consultative processes in a coordinated manner. Proficiency in standard office software. Ability to work autonomously, results-oriented, and meet deadlines.

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