The Regulatory Systems Advisor is a key technical leadership position that is responsible for leading and overseeing the regulatory systems strengthening technical strategy, approaches, tools and implementation of the program at the global and country level, supporting country-based technical activities, and ensuring high technical standards and program performance. The Advisor will lead strengthening national pharmaceutical regulatory systems in low- and middle-income countries, with a focus on strengthening institutional and human resources capacity for product registration, premise regulations, personnel regulations, medicine safety, and pharmacovigilance programs. The position supports the improvement and enforcement of government policies, regulations, guidelines, and procedures. The Advisor will ensure coordination and oversight, quality control, and capacity strengthening of pharmaceutical systems strengthening (PSS) expertise. S/he will be a thought leader in PSS and represent the program at conferences and other public forums to advance the understanding of PSS. The Advisor will work closely with the DPD/Technical Director and the Project Director and represent the program to USAID, representatives from collaborating country governments, and stakeholders.

SPECIFIC RESPONSIBILITIES: 

• Develop and oversee the implementation of the program’s overall technical vision and strategy for regulator systems strengthening.
• Ensure that the project identifies and addresses the technical expectations, needs, and interests of the donor and that the solutions reflect the strategies and design of the project.
• Develop and promote performance improvement culture and processes necessary for ongoing improvement of the effectiveness and efficiency of the implementation of the project’s technical approaches and tools at the country level.
• Ensure high-quality and timely technical assistance across all regulatory systems strengthening (RSS)  technical areas.
• Represent the program and its technical strategy externally; establish and maintain collaborative relationships and communication with USAID’s cross-bureau and global initiatives.
• Facilitate and participate in international events to interact with RSS and PSS stakeholders, experts, policymakers, and potential partners.
• Facilitate the generation of evidence-based interventions at the global, regional, and country levels.
• Write technical reports and publications on the project’s technical interventions and results.
• Coordinate with other technical area leads to ensure coordinated and integrated strategies, approaches, work streams, and high-quality deliverables.
• Ensure that project activities are compliant with SOPs and MSH policies.
• In collaboration with the management team, ensure that timely remedial actions are taken to mitigate risks.
• Participate in business development processes as requested.

QUALIFICATIONS:

Graduate degree in a health-related field with specialized training and/or experience relating to pharmaceutical systems and regulatory affairs required. Pharmacist or Medicine qualification preferred A minimum of eight years of experience working, or senior level advising at a national or regional regulatory authority for low and middle-income countries (LMICs) or provision of technical assistance in RSS preferred. Significant relevant experience in managing or overseeing activities in the area of pharmaceutical regulatory systems, particularly in pharmaceutical policy, marketing authorization, medicine control and regulatory affairs, pharmacovigilance, medicine selection, and/or health technology assessments, in LMICs required. Relevant experience and knowledge of global regulatory systems initiatives under the WHO, AUDA-NEPAD, SEARN, etc strongly preferred Relevant experience in international public health with experience in pharmaceutical services and systems strengthening, particularly related to the implementation of reproductive health; maternal and child health; HIV/AIDS; malaria; neglected tropical diseases; and tuberculosis prevention, care, and treatment programs in developing countries, strongly preferred. Demonstrated senior-level leadership to programs of similar magnitude and complexity including achieving sustainability and resiliency is preferred.