Pharmaceutical Regulatory Quality Management Advisor / Asesor en gestión de la calidad regulatoria farmacéutica, DOS LEAP Global - Guatemala

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LEAP Program Description

Global Solutions Ventures (GSV) – a joint-venture partnership between ZemiTek, LLC and Dexis Consulting Group – is implementing the Long-term Exceptional Technical Assistance Project (LEAP Global), a mechanism originally used by USAID to battle against infectious diseases such as malaria, HIV/AIDS, tuberculosis, neglected tropical diseases, and pandemic influenza. As of July 1, 2025, LEAP Global transitioned to the U.S. Department of State (DOS). This initiative aims to address the complex human resource challenges faced by national infectious disease programs in the USA-supported countries.

The intervention of this project is to hire and embed technical expert advisors and subject matter experts within government entities. By directly embedding the technical expertise within the national programs, LEAP provides long-term, sustainable lifesaving support to empower host governments to lead and manage key aspects of their infectious disease portfolios and improve coordination between the U.S. Government and the host country.

About the Position

The Pharmaceutical Regulatory Quality Management Advisor will support the Ministry of Public Health of Public Health and Social Assistance (MSPAS), principally the Vice ministry of Regulation and Control of Pharmaceutical and Related Products in carrying out life-saving health assistance (LHA) in full alignment with the U.S. Presidential Executive Order (EO) directives. The primary focus of the Adviser will be technical support with a special emphasis on preventing, detecting, and responding to emerging infectious disease threats which impact public health.

The first workstream will strengthen regulatory contributions to preventing, detecting, and responding to emerging infectious disease threats. The second will preserve the Ministry-requested functions for sanitary registration, regulatory quality management, process simplification, and priority MCHN products.

Approximately 50 percent of the advisor's technical level of effort and outputs will be GHS-specific. These activities will focus on regulatory readiness for medical countermeasures and outbreak-response products, emergency regulatory procedures, product-quality alerts, data for rapid decision-making, and coordinated technical support during public health emergencies. The Advisor will support, but will not assume operational responsibility for, epidemiological detection, event notification, clinical case management, or outbreak command functions.

The remaining 50 percent will support the MSPAS Process Simplification Plan, reduction of the sanitary registration backlog, advancement from global benchmarking tools, development of a sustainable quality management system, and risk-based attention to medicines, supplements, and related products designated by MSPAS as priorities for maternal, newborn, and child health and nutrition.

The advisor will define the regulatory standards, processes, data, and quality requirements. The health information systems support project will lead the technological design and implementation for the future National Directorate of Medicines (DNM). The advisor will be based in Guatemala City for an anticipated twelve-month period, receive onsite direction from the Vice Minister of Regulation, maintain operational coordination with the Department Director, and report to the U.S. Embassy/U.S. Department of State as described below.

Responsibilities

The following sixteen technical activities establish an equal 50/50 allocation between GHS-specific work and the regulatory quality management/MCHN functions requested by MSPAS.

Workstream 1 - GHS-specific regulatory readiness and emerging infectious disease support (50%):

Regulatory readiness: Assess regulatory readiness to prevent, detect, and respond to emerging infectious disease threats, identifying bottlenecks affecting the availability, authorization, quality oversight, and recall of medical countermeasures and outbreak-response products.

Emergency procedures: Develop or update emergency regulatory standard operating procedures (SOPs) that define activation criteria, responsible authorities, expedited assessment and regulatory reliance pathways, emergency importation, documentation, notification, and corrective-action requirements.

Product-quality coordination: Strengthen regulatory coordination for product-quality signals, alerts, recalls, and suspected substandard or falsified products with epidemiological surveillance, public health laboratories, pharmacovigilance, logistics, customs, emergency response, and Agriculture or Environment authorities when a One Health, the intersection of human, animal and environmental health, interface is required. GHS data and indicators: Define GHS-specific regulatory data elements and performance indicators for digital platforms and dashboards, including event-to-regulatory-decision timelines and the regulatory contribution to the 7-1-7 target, without transferring responsibility for detection, notification, or response operations to the a

Outbreak readiness and response: Support outbreak readiness and response through timely advice on regulatory decisions, quality-assured product availability, product safety communications, recalls, and essential nutrition commodities when required during public health emergencies.

Tabletop review: Facilitate at least one tabletop review of the emergency regulatory pathway; document gaps, decisions, responsible parties, timelines, and corrective actions; and incorporate lessons learned into updated procedures.

Portfolio coordination: Coordinate the regulatory GHS workstream with relevant MSPAS units, U.S. Government-supported GHS projects, the Pandemic Fund where applicable, and other partners to align technical approaches, leverage resources, and avoid duplication.

GHS monitoring and reporting: Provide regulatory inputs for GHS monitoring and reporting aligned, as applicable, with the International Health Regulations (IHR), Joint External Evaluation (JEE), IHR States Parties Self-Assessment (SPAR), 7-1-7, Pandemic Fund, and U.S. Government workplans; identify and disseminate effective practices.

Workstream 2 - Regulatory quality management, process simplification, and MCHN (50%):

International regulatory diagnosis: Facilitate a self-assessment of the medicine registration quality management system and a gap analysis, covering the legal and regulatory framework, SOPs, staff capacity, document management, scientific assessment criteria, timelines, and transparency; prepare a diagnostic report.

Quality improvement plan: Develop a detailed quality improvement action plan with activities, timeline, required human/technical/financial resources, measurable indicators, responsible parties, and recommendations for legal and regulatory updates needed to advance toward the next level.

SOPs, quality system, and capacity building: Develop or update SOPs for technical and scientific assessment, document control, quality assurance, and continuous improvement; establish the proposed quality management system; train personnel; transfer knowledge; and support documentation readiness for a future external assessment.

Process simplification: Support the monitoring and use of the current medicine registration and control system, support the development of the new system, and reduce the registration backlog through prioritized workflows, continuous-improvement methods, staff support, progress monitoring, and resolution of regulatory and quality-management bott