USP
seeks a Registration and Dossier 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 Registration and
Dossier Expert consultant will support USP by strengthening ACOREPs regulatory
systems, specifically registration/marketing authorization and evaluation of
technical dossiers for registration to support attainment of GBT ML3. 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 registration and market authorization as necessary.
· Support mapping of all regulatory processes and functions
against GBT ML3 requirements and regulatory best practices.
· Align processes and procedures with WHO
guidelines and international best practices for national regulatory systems,
drug registration and marketing authorization, and other key regulatory
functions.
· Develop training materials, provide technical assistance,
and conduct workshops to support the adoption and implementation of developed
processes and procedures.
· Serve as a technical resource among USP technical RSS staff
on registration, market authorization, and technical dossier review.
· Facilitate collaboration with relevant stakeholders
including customs, law enforcement, health programs, regional initiatives,
manufacturers, distributors, and healthcare providers.
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 national regulatory systems,
drug registration and marketing authorization, and other key regulatory
functions.
· Demonstrated direct expertise in the evaluation
of technical dossiers for registration, with mastery of quality, safety, and
efficacy modules; 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 for registration and market authorization, and other relevant
national, regional, and international guidelines for registration, market
authorization, and technical dossier requirements.
· 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 other selected
languages preferred: French.
· 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 “Registration and Dossier 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.
