The Consultant for Regulatory System Strengthening (RSS) is a key position within the Ethiopia Promoting the Quality of Medicines Plus (PQM+) program. They provide strategic direction and overall technical oversight to PQM+ Ethiopia RSS activities ensuring realization of program objectives. The Senior Technical Advisor advises USAID and PQM+ Ethiopia on all matters related to strengthening country regulatory systems for quality assurance of medical products and to the improvement of their governance and transparency practices. They collaborate with other Team Leads in Ethiopia to promote and optimize financial resources for quality assurance and to advance the global medical product quality assurance learning agenda. They will be direct program resources to strengthening regulatory functions as delineated by the WHO GBT with emphasis on market authorization (MA), regulatory inspections, GBT of EFDA and capacitating regional regulatory bodies in Ethiopia. The Senior Technical Advisor also promotes the advancement of regulatory governance, transparency, and regional harmonization
Key Responsibilities
· Provide technical support in defining and developing RSS technical strategies, approaches, and tools that align with international standards for medical products regulation (such as those from WHO, ICH, PIC/S, ISO, USP, and other recognized standards) necessary for the delivery of PQM+ RSS technical assistance in Ethiopia.
· Support EFDA and regional regulators to adopt new and emerging regulatory pathways (such as EUA, FRP, and CRP) and efficient regulatory approaches (such as joint reviews, reliance, and recognition) and to develop their regulatory science capacity to ensure timely approval and life cycle monitoring for the quality, safety, and effectiveness of medical products in their market.
· Collaborate with PQM+ countries to oversee the implementation of RSS activities and to ensure the adequate deployment of needed resources and tools for the delivery of technical assistance aimed at supporting countries’ regulatory agencies to progress towards higher WHO maturity levels.
· Support the development, deployment and continuous improvement of strategy and approaches to advance regulatory harmonization in the region.
· Collaborate with MEL team to ensure the development and deployment of effective RSS indicators and for program reporting on RSS activities.
· In collaboration with PQM+ communication team, develop and oversee implementation of documentation and dissemination plans that capture RSS lessons learned, success stories, best practices and program adopted approaches
Qualifications and Experience
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
· Master’s degree in international regulatory affairs, pharmaceutical sciences, chemistry, public health, or related field.
· Experience in dossier submission and review practices of WHO, FDA, and other stringent agencies.
· Previous experience in the deployment of international standards such as those from WHO-GBT, ICH, PIC/S, ISO, USP, etc. to support LMIC regulatory agencies.
· Expertise in the development of manuals, SOPs, and quality management systems to support the delivery of regulatory functions.
· Eight (8) years in designing and implementing projects that contribute to stronger health systems and improve health outcomes in low- and middle-income countries.
· Three (3) years people management experience and skills, including ability to seamlessly manage virtual teams and work in a matrixed organization
Additional Desired Preferences
· Doctoral degree in regulatory affairs, pharmaceutical sciences, chemistry, public health, or related field.
· Previous work as a regulator with experiences in market authorization and review, regulatory inspection, post marketing surveillance, and in crosscutting areas including harmonization, reliance, and recognition.
· Direct experience with and understanding of the WHO Global Benchmarking Tool
IMPORTANT Note: This opportunity is only available to Ethiopian nationals or holders of work permits and permanent residence permits for Ethiopia.
Period of Performance
January 2024 – September 2024.
Please send CV, 3-References, and Hourly Rate in US$ to ATTN: Hana Keno, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of December 21, 2023. When submitting your application, write “Regulatory Systems Strengthening - RSS Consultant- Ethiopia” in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. In 2019, USP was awarded the Promoting the Quality of Medicines Plus (PQM+) program, a 5-year USAID-funded global program designed to sustainably strengthen medical product quality assurance (QA) systems in low-and-middle income countries. The main objectives of PQM+ program include: to improve governance of medical product QA systems, improve country and regional regulatory QA systems, optimize, and increase financial resources for QA, increase supply (manufacture) of quality-assured essential medicines and advance global learning and operational agenda, for medical products quality assurance.
