Summary of the Position
The Technical Advisor, Regulatory Systems Strengthening (RSS) will provide technical assistance to the Kenya Pharmacy and Poisons Board and Ministry of Health to build their capacity to regulate the pharmaceutical market in Kenya. They must possess a deep understanding of the pharmaceutical regulatory environment in low income and middle-income countries. As the focal point for PQM+ Kenya in RSS, the Technical Advisor provides technical oversight related to the program’s objective of strengthening regulatory capacity in registration, inspections, post-marketing surveillance and other regulatory functions associated with quality assurance. Additionally, he/ she is a recognized leader, who will also support AUDA-NEPAD initiatives in the pharmaceutical sector.
Roles and Responsibilities
Provides technical oversight of activities to support the regulatory functions of the PPB
In collaboration with other partners, support PPB to review its operational processes, including regulatory aspects, to improve market authorization, inspection, post-marketing surveillance, and enforcement systems
Support PPB to review and strengthen pharmaceutical registration processes and systems.
Supports AUDA-NEPAD in coordinating and executing regional activities in support of the African Medicines Regulatory Harmonization initiative
Leads the roll-out of risk-based post marketing surveillance and the uptake and application of the MedRS tool
Supports the work and efforts of the Technical Director and the center of excellence to develop technical documents on regulatory system strengthening.
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 medical products
Keep abreast of the latest regulatory trends and WHO guidance
Technical point of contact for local WHO office and other stakeholders
Represents the organization in local and regional forums on RSS
Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
Basic Qualifications
Bachelor’s degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required
Ten (10) years of relative experience in regulatory system strengthening related work preferably with organizations such as USAID, World Health Organization or any of the UN agencies.
Five (5) years of people management experience and skills
Subject matter expert in one of the following national pharmaceutical regulatory systems, pharmaceutical policy/regulations, market authorization, post-market surveillance, licensing or inspections.
Knowledge of international regulatory guidelines**
Demonstrated experience in implementing regulatory systems**
Strong written (especially technical writing) and oral communication skills
Willingness to travel at least 25% of the time.**
Preferred Qualifications
Direct experience implementing USAID-funded programs
Direct experience with and understanding of WHO global benchmarking tool**
Experience working with AUDA-NEPAD on the African Medicines Regulatory Harmonization initiative
Supervisory Responsibilities
Reports will scale with program growth and will include relevant technical staff
