USP seeks two (2) regulatory systems strengthening experts with knowledge and experience in building the capacity of national regulatory authorities to enhance their maturity level on the WHO Global Benchmarking Tool (GBT). Specifically, we seek experts with hands-on experience i working with or in NRAs to implement interventions for various regulatory functions including assessing national regulatory systems capacity building and implementing relevant interventions. The consultant(s) will work directly with USP’s Global Health Technical Program (GHTP) team in the Global Health & Manufacturing Services (GHMS) division.
Some tasks that the consultants/vendors may be required to perform include:
· In collaboration with USP team, build the capacity of NRA staff in required regulatory functions including marketing authorization, licensing, market surveillance and control, vigilance, inspection, laboratory testing, clinical trials, and lot release.
· Provide technical assistance to NRA staff in self-assessment, including training on the use of assessment tools and hands-on support for assessing relevant regulatory functions.
· Review adequacy of documents provided by NRA staff to support self-assessment scores for relevant functions.
· Review, update and suggest revisions to institutional development plans for assessed regulatory functions.
· Monitor and ensure progress with implementation of developed IDPs for relevant functions according to an agreed timeline.
· Provide periodic updates to the USP team through reports or check-in meetings on progress with strengthening the capacity of relevant assigned regulatory functions.
· Perform tasks related to regulatory system strengthening as may be required by the supported country and agreed upon with the USP team
· Support efforts to harmonize regulatory requirements at regional levels
· Support the development and implementation of interventions to strengthen pharmaceutical services including product selection, product prioritization, pharmaceutical workforce development, resource mobilization, etc.
· Engage private sector stakeholders as necessary in the provision of pharmaceutical services at the country or regional level
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Qualifications and Experience
· Education: At least master’s degree or equivalent in Regulatory Science, Pharmacy, Pharmaceutical Science, Public Health, Medicine, Chemistry, Biology, or related fields
· Years of experience: A minimum of 10 years of professional experience in the regulation of medical products with at least 8 of those years directly related to supporting the development of regulatory functions in or within a national or regional regulatory authority or the pharmaceutical industry.
Technical skills:
· Knowledge and demonstrated experience with supporting NRAs to strengthen one or more of the regulatory functions contained in the WHO GBT to attain a higher maturity level.
· Familiarity with using the WHO GBT to assess one or more regulatory functions and supporting the development of institutional development plans (IDPs) for the relevant functions is desirable.
· Experience working in one or more countries in Asia, North Africa and or the Middle Eastern region is an added advantage.
· Experience with developing regulatory and or pharmaceutical services interventions at national or regional levels
· Demonstrated experience in supporting regional harmonization efforts
· Ability to travel internationally (if applicable)
Non-technical skills:
· Excellent written and oral communication skills, including experience in training and mentoring staff and others.
· Ability to write good, coherent and information rich reports.
· Fluency in English is required. Fluency in other languages including Arabic, Spanish, Portuguese, and French is an added advantage.
Period of Performance
The period of performance and required number of hours/days will vary depending on the specific assignment.
APPLICATION SUBMISSION REQUIREMENTS
Please send your CV to gph_procurement@usp.org by the 04/15/2024. When submitting your application, write “Call for Regulatory System Strengthening/Assessment Consultant” in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality, and beneficial medicines. We work to strengthen regulatory systems and the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medicines, strengthen national and regional regulatory system and initiatives, and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.
