USP
seeks a BA/BE expert for an anticipated 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 BA/BE consultant will support
USP by strengthening the capacity of ACOREP to implement requirements for BE
studies to support attainment of GBT ML3 and ensure generic product quality. The
expert will be responsible for drafting regulations, procedures, and guidance,
training delivery, providing technical assistance, conducting assessments, and
mentoring regulatory and quality assurance teams.
**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:
· Review and update national guidelines, SOPs, and
policies for bioequivalence study requirements as necessary
· Align processes and procedures with WHO
guidelines and international best practices for bioequivalence and clinical
trial assessment, Contract Research Organization (CRO) inspections,
pharmacokinetic analysis, and Good Clinical Practice (GCP) compliance.
· Develop training materials, provide technical assistance,
and conduct workshops to support the adoption and implementation of developed
processes and procedures.
· Facilitate collaboration with relevant stakeholders
including manufacturers, clinical sites, health programs, regional initiatives,
and healthcare providers.
· Support development of strategies to facilitate
the establishment of bioequivalence centers
Qualifications
· Have 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 review of bioequivalence
studies and inspections of CROs or clinical trial sites.
· Demonstrated direct expertise in the evaluation
of technical dossiers for registration, with mastery of the efficacy module;
demonstrated experience in capacity building for the evaluation of technical
dossiers.
· Expertise in developing regulatory documents
required for national regulatory systems.
· Knowledge of and experience with: WHO guidelines, WHO GBT
requirements, and relevant national, regional, and international guidelines
related to BA/BE requirements (including ICH E3, E6, M9, M10, M13)
· Excellent written and oral communication skills,
including experience in training and mentoring staff and others
Non-technical Qualifications
· Resides in Africa Region.
· Fluency in English is required. Fluency in French
preferred.
· Ability to travel internationally for up to 25%
of the time (if applicable)
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 December 19, 2025. When submitting your
applications, please write “BA/BE
Expert (Africa Region)” 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.
