Company: U.S. Pharmacopeial Convention
Position: Technical Advisor, Regulatory Systems Strengthening (RSS)
Number of Vacancies: 1
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor- quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.
USP is seeking for a Technical Advisor, Regulatory Systems Strengthening (RSS) in support of PQM+ program implementation in Nepal.
Under the guidance of the Chief of Party, the Technical Advisor, RSS will provide technical assistance to the Department of Drug Administration (DDA) and Ministry of Health to build their capacity to regulate the pharmaceutical market in Nepal. S/he must possess a deep understanding of pharmaceutical regulatory environment in low income and middle-income countries. As the focal point for PQM+ Nepal 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, s/he acts is a recognized leader, interfacing with DDA and stakeholders.
Scope of Work:
• Provides technical oversight of activities to support
• In collaboration with other partners, support DDA to review its operational processes, including regulatory aspects, to improve market authorization, inspection, post-marketing surveillance, and enforcement systems
• Support DDA to review and strengthen pharmaceutical registration processes and systems.
• 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
• Minimum of 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.
• Bachelor’s degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required
• Subject matter expert in any of the following national 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.
• Direct experience implementing USAID-funded programs
• Minimum of 5+ years of people management experience and skills
• Direct experience with and understanding of WHO global benchmarking tool
• Experience in PIC/S
Last date to apply: 27th April 2020
HOW TO APPLY
Interested candidates should submit cover letter, CV, and USAID Form 1420 (available at https://www.usaid.gov/forms/aid-1420-17) by email to GPHNepalRecruitment@USP.org clearly stating Technical Advisor RSS in the subject line of the e-mail.