Technical Advisor – Regulatory System Strengthening (RSS)

Technical Advisor – Regulatory System Strengthening (RSS)

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 System Strengthening (RSS) in support of PQM+ program implementation in Nepal.

Summary of the Position

The Technical Advisor will technically support PQM+ Nepal team in coordination with the chief of party, deputy chief of party, senior technical advisors, technical advisors and in collaboration with the Department of Drug Administration, National Medicine Laboratory, Public and Private Manufacturers and other relevant stakeholders to improve the quality of medicine in Nepal. The Technical Advisor will lead initiatives to institutionalize policies, conduct capacity-building activities, and facilitate stakeholder consultations, ensuring the sustainable development of Nepal's pharmaceutical regulatory framework. This position demands strong leadership and expertise in regulatory systems to ensure the availability of safe, effective, and quality-assured medicines.

Roles and Responsibilities

Under the supervision and direction of the Senior Technical Advisor (STA) –the Technical Advisor:

• Support Chief of Party of PQM+ Nepal to provide technical support to PQM+ Nepal overall activities and workplan.
• Coordinate with in-country DCoP and Senior Technical Advisors to strengthen Regulatory functions, quality assurance and control systems at the Department of Drug Administration, National Medicine Laboratory, local medicine manufacturers (both public and private allopathic manufacturers) and help build awareness of the threat of SF medical products.
• Coordinate and Support the the institutionalization and implementation of DDA's Quality Management System (QMS) in line with WHO's GBT framework and ISO 9001:2015 standards.
• Coordinate and contribute to the drafting and implementation of GS-1 standards for traceability of medicines and vaccines.
• Assist in the development and finalization of national regulations, guidelines, and policies, including the Draft Drugs Act 
• Coordinate and support in institutionalization of NML’s five-year strategic costed plan (2023-2027)
• Support in organizing a multistakeholder advocacy meeting to address pharmaceutical sector related issues and build awareness of the threat of substandard and falsified (SF) medical products.
• Support DDA and NML in GBT assessment process and its institutional development plan
• Support DDA and NML in HR strategies and capacity building activities.

Basic Qualifications

• Bachelor’s degree in pharmacy, chemistry, microbiology, or related field; a higher degree will be an advantage.
• At least 5 years of experience in regulatory system strengthening program including quality policy and strategy development control in LMICs.
• Experience in drafting documents on pharmaceutical policy, strategies, and regulations.
• Knowledge of Good Manufacturing Practices (GDP), Good Distribution Practices (GDP), Good Storage Practices (GSP), and good laboratory practices (GLP) norms in related fields.
• In depth knowledge about international best practices in pharmaceutical sector.

Preferred Qualifications

• Experience with virtual teams based in low- and middle-income countries.
• Experience in regulatory system strengthening.
• Pharmacist, Physician or other health profession qualification highly desirable.
• Proof of experience working effectively, timely, and quality implementation of donor-funded (particularly USAID-funded) global health or international development projects.
• Good understanding of and experience working with USAID compliance rules and regulations.
• Strong team player, including of virtual, matrixed teams.
• Excellent client relationship management skills.
• Excellent written and verbal communication skills.
• Ability to work in cross-cultural settings.
• Ability to demonstrate the highest degree of ethics and integrity.

Application Process:

Interested candidates should submit cover letter, CV by email to GPHNepalRecruitment@USP.org clearly stating Technical Advisor - Regulatory System Strengthening (RSS) in the subject line of the e-mail. 

Application Deadline:  July 22, 2024