Senior Advisor – Pharmaceutical Regulatory System Strengthening

About the role

The Senior Advisor will provide high‑level strategic and technical support to the Ethiopian Food and Drug Authority (EFDA) to strengthen its pharmaceutical regulatory system. The role focuses on improving regulatory service efficiency, supporting the national rollout of a GS1‑compliant track‑and‑trace system, and preparing EFDA for ISO 9001:2015 certification.

Key responsibilities

• Advise EFDA leadership on strategic regulatory system strengthening.
• Assist in drafting, revising, and operationalizing proclamations, regulations, guidelines, and SOPs related to product registration, customs clearance, and traceability.
• Support harmonisation of national frameworks with WHO, ISO 9001, and GS1 standards.
• Establish and strengthen governance structures such as technical working groups and steering committees.
• Identify regulatory bottlenecks and propose corrective measures for import permits and customs clearance of USG‑supported health commodities.
• Facilitate the implementation of the national pharmaceutical traceability roadmap and the e‑RIS platform.
• Mentor and coach EFDA staff to build sustainable institutional capacity.

Required profile

• Extensive experience in pharmaceutical regulatory affairs and public‑health commodity management.
• Proven ability to work with government agencies and international donors.
• Strong analytical skills for regulatory reform and performance‑driven decision‑making.
• Excellent communication and stakeholder‑engagement capabilities.

Required skills

• Knowledge of GS1 standards for product traceability.
• Familiarity with ISO 9001:2015 quality management systems.
• Experience with electronic regulatory information systems (e‑RIS).
• Understanding of customs clearance processes for health commodities.