USP seeks a Regulatory Affairs consultant with expertise in Lot Release 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 a strategy to strengthen local production of medicines and vaccines. The Regulatory Affairs consultant will support USP by establishing a Lot Release function within ACOREP and building the capacity of staff on key aspects of Lot Release toward attainment of Maturity level 3 for this function.
**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:
· Working with relevant legal experts, support ACOREP to define the regulatory framework including legal provisions, regulations, policies and guidelines for independent lot release by the NRA in line with international best practices including provisions for regulatory reliance
· Support the DRC to define the organizational structure for lot release function with the roles and responsibilities for all relevant regulatory
entities involved, and communication and coordination mechanisms agreed and clearly documented.
· Work with ACOREP to draft or revise job descriptions for staff involved in Lot Release, develop a training plan and support capacity building for relevant staff
· Support the drafting of relevant procedures including standard operating procedures, guidelines, evaluation procedures, for undertaking independent lot release activities, communicating and sharing results of lot release processes with relevant stakeholders, by the NRA
according to international standards and best practices
· Support ACOREP to establish a system for periodic monitoring performance of the independent lot release function in accordance with the WHO GBT.
· Support implementation of any other activity (as may be needed) for DRC to attain WHO maturity level 3 on the independent lot release
function.
Qualifications
· a university degree (minimum 5 years of higher education) in pharmaceutical sciences, medicine, chemistry, biochemistry, or biology.
· at least 7 years of international experience in strengthening regulatory systems - particularly in national regulatory systems, lot release function or vaccine quality and safety monitoring , and other key regulatory functions.
· Expertise in establishing the regulatory function of batch release and in capacity building for batch release in an LMIC setting.
· Expertise in the field of pharmacovigilance (PV) with a track record in developing PV-related documents and capacity building for the
implementation of best practices in pharmacovigilance.
Preferred Qualifications
· Experience in building institutional and individual capacity in the LMIC context including use of the WHO GBT to assess and strengthen NRA capacity
· Experience working with the pharmaceutical industry on vaccine development and production
· Fluency in both English and French languages is an added advantage
· Located in Africa Region
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 22, 2025. When submitting your applications, please write “Regulatory Affairs: Lot Release” 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.
