Job Description
- 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.
- Reports will scale with program growth and will include relevant technical staff.
- USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
Job Requirements
- 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.
- Demonstrated experience in developing and implementing regulatory systems strengthening interventions obtained from working with national regulatory authorities or with implementing partners.
- Demonstrated experience in one or more of the following disease areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
- Direct experience implementing USAID-funded programs.
- Strong written (especially technical writing) and oral communication skills with strong ability to dialogue and interact effectively with high-level officials.
- Willingness to travel at least 25% of the time.
- 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
More Information
- Address Ethiopia