Legal Expert – Pharmaceutical Law DRC

Job Description

USP seeks a Legal Expert in Pharmaceutical Law 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 Legal Expert will
support USP in drafting,
reviewing, and finalizing a national pharmaceutical products legislation legal
framework. The expert must demonstrate a strong understanding of the
pharmaceutical regulatory landscape and ecosystem in Africa and have direct
experience working with national regulatory authorities to strengthen legal
frameworks in line with applicable standards and model laws.

**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 medical products legislation and regulations.
• Draft national medical products with regulatory legislation and regulations.
• Convene stakeholders to review and finalize national medical products with
  regulatory legislation and regulations.
• Train and sensitize relevant stakeholders on proposed legislation and regulations.
• Provide technical advice on legal frameworks for national regulatory authorities.

Qualifications

· Hold a law degree

· Be able to propose and analyze legislative and regulatory
texts on pharmaceutical products.

· At least 5 years of experience in proposing and analyzing
legislative and regulatory texts concerning pharmaceutical products.

· Thorough understanding of the African Union Model Law for
medical products regulation and experience in its adoption by countries on the
continent.

· Solid understanding of the functions of an NRA as prescribed
in the WHO Global Benchmarking Tool.

· Demonstrate a strong understanding of the pharmaceutical
regulatory landscape and ecosystem in the DRC or similar contexts.

· Fluency in English is required. Fluency in French Preferred.

· Strong written (especially technical writing) and oral
communication skills in English, French, or both.

· Reside in the DRC.

Preferred Qualifications

· Demonstrated experience working with organizations providing
technical assistance to strengthen pharmaceutical legislative and regulatory
frameworks.

· 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 November 30, 2025. When submitting your
applications, please write “Legal Expert – Pharmaceutical Law DRC” in
the email Subject Line of your email.

About the Organization

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.