Senior Technical Officer, Regulatory Systems Strengthening (RSS) at US Pharmacopeial Convention (USP)

Supervisory Responsibilities: None

Summary of the Position

• The Senior Technical Officer, Regulatory Systems Strengthening (RSS) will provide technical assistance to medicines regulatory authorities (MRAs) and Ministries of Health in francophone countries in West Africa.
• The Senior Technical Officer 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 francophone countries in West Africa.
• The Senior Technical Officer, 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 West African countries. A primary focus of the role will be the implementation of risk-based approaches including post-market surveillance.

Roles and Responsibilities

• Leads in the roll-out of risk-based post-marketing surveillance in west African countries
• Identifies gaps in key medicines regulatory functions and recommends areas of improvement
• Provide guidance in the development and implementation of institutional development plans to address findings from WHO Global benchmarking assessments
• Identify and access trends in medicines regulatory activities
• Leeds in organizational and human capacity building efforts across select regulatory functions
• Liaises with medicines regulatory authorities and laboratories in francophone countries to facilitate information sharing related to medicine quality assurance
• Contributes to the development of PQM+ strategies applicable to francophone countries
• Supports the PQM+ program team in work plan development, implementation and reporting
• Facilitates the development of in-house training programs to ensure sustainability and transfer of knowledge
• Provide oversight for local RSS staff, local partners and consultants involved in the regulation of medical products
• Actively engages with the WestAfrican 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.
• May support national quality control laboratory efforts to improve quality management systems and overall testing capacity.
• Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports.

Basic Qualifications

• Eight (8) years experience working in pharmaceutical regulatory affairs in at least one of the following regulatory functions - post-market surveillance, dossier review or inspections.
• Working knowledge and understanding of regulatory systems strengthening in francophone countries in Africa
• B.Sc in Pharmacy, Pharmaceutical Science, Chemistry, Engineering or Science related field of study required
• Fluent in French - written and oral.

Skills Sought:

• Strong written (especially technical writing) and oral communication skills
• Direct experience with and understanding of WHO global benchmarking tool
• Willingness to travel at least 25% of the time.

Preferred Qualifications:

• Experience in at least one of the following health areas: HIV/AIDS, malaria, TB, NTDs, AMR, MNCH
• Direct experience implementing USAID-funded programs
• Minimum of 3+ years of people management experience and skills.