Senior Technical Advisor, RSS - Africa at US Pharmacopeia

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

Basic Qualifications

• 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

Preferred Qualifications

• 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