USP seeks an Information Systems & Regulatory Process Digitization Consultant for a potential 3-year project in DRC, where USP will provide assistance towards strengthening the maturity level of the National Pharmaceutical Regulatory Authority (ACOREP), strengthening capacities of the National Quality Control Laboratory, and developing strategy to strengthen local production of medicines and vaccines. The expert will support ACOREP to acquire and operationalize an integrated regulatory information management system (IRIMS) for its main regulatory functions to improve and streamline its regulatory processes to increase consistency, transparency and efficiency of critical regulatory processes and operations.
**This opportunity is connected to a proposal. Any consultant engagement is contingent upon contract award.**
Roles and Responsibilities
Potential tasks that the consultant/vendor will be responsible for carrying out include:
· Develop a tool to conduct a feasibility assessment for an IRIMS at ACOREP
· Conduct feasibility assessment for an IRIMS and develop the feasibility report
· Develop the specifications for an IRIMS solution for ACOREP to guide its acquisition.
· Provide technical guidance through the process of acquiring IRIMS for ACOREP
· Provide oversight through the process of installation, deployment and operationalization of the IRIMS.
Qualifications
· Have at least a degree in computer science and programming;
· Have at least 7 years of international experience in the digitization of regulatory information management.
· Have a good understanding of how a national regulatory authority operates.
Preferred Qualifications
· Resides in the Africa Region (Please specify countries of experience).
· Demonstrated experience leading the establishment of electronic regulatory information management solutions for NRAs.
· Direct experience implementing donor-funded programs.
Application Procedure Please send your CV, Cover Letter, 3 References, and hourly rate (in USD) to GPH_Procurement@USP.org, by the closing date of October 24, 2025. When submitting your applications, please write “Information Systems & Regulatory Process Digitization” in the email Subject Line of your email.
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. USP’s Global Health programs have reached more than 90 countries across Africa, Asia, and North and South America to strengthen global supply chains and pharmaceutical ecosystems that enable a resilient supply of quality medical products.
