Pharmaceutical Regulatory Quality Management Advisor

About the role

The Pharmaceutical Regulatory Quality Management Advisor will work with the Ministry of Public Health and Social Assistance (MSPAS) to strengthen regulatory systems that prevent, detect, and respond to emerging infectious disease threats. The position is part of the LEAP Global project, a long‑term technical assistance initiative transitioning to the U.S. Department of State.

Key responsibilities

• Provide technical support to the Vice Ministry of Regulation and Control of Pharmaceutical and Related Products on regulatory quality management and sanitary registration.
• Assist in developing emergency regulatory procedures, product‑quality alerts, and rapid‑decision data for medical countermeasures.
• Contribute to process simplification and prioritization of maternal‑child‑health‑nutrition (MCHN) products.
• Collaborate with GHS‑specific workstreams to ensure readiness for outbreak‑response products.
• Support coordination between U.S. government agencies and host‑country health authorities during public‑health emergencies.

Required profile

• Experience in pharmaceutical regulatory affairs, preferably within government or international health programs.
• Familiarity with regulatory quality management frameworks and sanitary registration processes.
• Understanding of emergency health‑response mechanisms and medical countermeasure readiness.

Required skills

What we offer

• Opportunity to influence health security in USA‑supported countries.
• Collaboration with a joint‑venture team of ZemiTek and Dexis Consulting Group.
• Engagement in a high‑impact, government‑level technical assistance project.