The U.S. Pharmacopeial Convention (USP) (Senior) Technical Advisor in Tashkent, Uzbekistan
Summary of the Position
The Senior Technical Advisor, Regulatory Systems Strengthening (RSS) will provide technical assistance to the Agency on Development of the Pharmaceutical Industry (Agency) in Tashkent. S/he will also provide technical assistance to the medicines regulatory authorities (MRAs) of Kazakhstan and Tajikistan. The incumbent will support the delivery of PQM+ activities in a dynamic, fast-paced environment, and is responsible for day-to-day technical implementation of PQM+ activities. The Senior Technical Advisor will have functional reporting to the Rockville based PQM+ Senior Technical Advisor, RSS and will work under his/her guidance with additional support from the Technical Advisors, to ensure technical approaches and strategies are applied appropriately. S/he will also liaise with donors, national counterparts, GHMS staff, and consultants to facilitate program implementation.
Roles and Responsibilities
Partner with the Director, Health Elements, Program Manager, and Senior Technical Advisor, RSS to implement RSS technical activities as outlined in the work plan
Provide consistent, high-quality, and results-driven technical assistance to the MRAs to develop their capacity through assessment, training, document review and standardization, development and dissemination of tools and job-aids amongst others
Lead the development of medicines regulatory policies impacting medicine quality and work with the MRAs and Ministries of Health (MoH) to develop policies, enabling strengthening of medicines quality assurance systems in the countries.
Advises MRAs on interventions to address institutional development plans based on the findings of WHO Global Benchmarking or PQM+ assessments of the relevant countries
Facilitates the development of in-house training programs to ensure sustainability and transfer of knowledge
Supports the PQM+ Center of Excellence in developing and disseminating PQM+ approach related to different regulatory functions
Keep abreast of the latest regulatory trends and WHO guidance
Actively contributes to annual programmatic and resource planning process and to the development of quarterly and annual reports
Provide trainings in collaboration with the Senior Technical Advisor and Technical Advisor, RSS to the staff of the Agency in regulatory functional areas as needs are identified
Provide technical assistance to PQM+ supported manufacturers in ensuring regulatory compliance
Collect and report data on approved indicators as defined in the monitoring evaluation and learning (MEL) plan
Review and provide timely inputs into key project deliverables including work plans and reports
Contribute to defining and refining the program’s RSS strategy and approach to ensure alignment with international best-practices
Timely preparation and submission of technical assessment and travel reports.
Identify technical challenges and risks as well as resolve issues in collaboration with the Senior Technical advisor, RSS, and other team members
Develop and present to groups/ external stakeholders in relevant areas, including WHO, regulatory forums/ authorities, and other leaders in health system strengthening
10 years’ experience working in pharmaceutical regulatory affairs or manufacturing in at least one of the following regulatory functions – product dossier review and registration, post-market surveillance, quality assurance/quality control or inspections.
Demonstrated experience in developing and implementing regulatory systems strengthening interventions obtained from working with national regulatory authority or with the pharmaceutical industry
Fluent in written and spoken Uzbek and Russian languages
Strong written (especially technical writing) and oral communication skills
Demonstrated experience working and leading various departments in a national medicines regulatory authority, pharmaceutical manufacturer or organization providing technical assistance to strengthen medicines quality assurance systems
Twelve or more years’ experience in in pharmaceutical regulatory affairs
Working experience with assessment tools (e.g., WHO Benchmarking Tool-GBT) to evaluate key functions of a medicine’s regulatory authority
Fluent in written and spoken English
Job Category Technical Programs
Job Type Full-Time