The U.S. Pharmacopeial Convention (USP) Senior Technical Advisor, RSS - Africa in Lavington, Kenya
The Senior Technical Advisor, Regulatory Systems Strengthening (RSS) will provide technical assistance to medicines regulatory authorities (MRAs) and Ministries of Health in Africa. The Senior Technical Advisor will work closely with Senior Technical Advisors and Technical Advisors as part of the PQM+ Center of Excellence to ensure the PQM+ technical approaches and strategies are appropriate for countries in Africa. The Senior Technical Advisor, RSS is a regional role and will therefore have functional reporting to the Senior Technical Advisor, RSS based in Rockville. The incumbent will lead the delivery of PQM+ activities in African countries in close coordination and working relationship with the country senior technical advisors and/or officers, chiefs of parties and regional directors. A primary focus of the role will be the development and implementation of risk-based approaches, including emergency use authorization, risk-based dossier evaluation for registration / marketing authorization, risk-based inspection, and post-marketing surveillance. The incumbent will also lead the PQM+ country national regulatory authorities (NMRAs) in Africa region toward next maturity level of the WHO Global Bench-Marking Tool (GBT).
This position will be based in a PQM+ presence country in Africa, including Kenya, Ghana, Ethiopia, Rwanda or Nigeria.
Roles and Responsibilities
PQM+ regulatory systems strengthening lead in the Africa region
Leads in the development of medicines regulatory policies impacting medicine quality and will work with the heads of NMRAs and MoH to develop policies to strengthen the pharmaceutical sector in Africa
Identifies gaps in key medicines regulatory functions and recommends areas of improvement
Provides guidance in the development and implementation of institutional development plans to address findings from WHO Global Bench-marking Assessment Tool (GBT)
Identifies regulatory gaps related to access to medicines, and develop activities to address the gaps
Leads in organizational and human capacity building efforts across select medicines regulatory functions
Facilitates the development of in-house training programs to ensure sustainability and transfer of knowledge
Liaises with medicines regulatory authorities to facilitate information sharing related to medicine quality assurance of medical products
Contributes to the development of global strategies and documentation of best approaches and practices that promote the PQM+ program visibility
Supports the PQM+ program team in work plan development and implementation
Provides oversight for local RSS staff, local partners and consultants involved in the regulation of medical products
Actively collaborates with the Africa regional harmonization initiatives e.g. the African Medicines Regulatory Harmonization (AMRH) Initiative, Africa Medical Devices Forum (AMDF), African Medicines West African Health Organization (WAHO) and other initiatives in the regions
Prepares and shares analytical results and insights with national medicines regulatory authorities, ministries of health and local USAID missions.
Actively contributes to annual programmatic and resource planning process and to the development of quarterly and annual reports
Ten (10) years’ experience working in pharmaceutical regulatory affairs in at least one of the following regulatory functions – registration/market authorization, post-market surveillance, and inspections
Working knowledge and understanding of regulatory systems strengthening in countries in Africa
S. in pharmacy, pharmaceutical science, chemistry, engineering, or science related field of study required
Strong written (especially technical writing) and oral communication skills
Direct experience with and understanding of WHO global benchmarking tool
Fluent in French
Willingness to travel at least 30% of the time
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Job Category Technical Programs
Job Type Full-Time