Senior Technical Advisor - Regulatory Systems Strengthening
Management Sciences for Health (MSH), a global health nonprofit organization, uses proven approaches developed over 40 years to help leaders, health managers, and communities in developing nations build stronger health systems for greater health impact. We work to save lives by closing the gap between knowledge and action in public health. Since its founding in 1971, MSH has worked in over 150 countries with policy makers, health professionals, and health care consumers to improve the quality, availability and affordability of health services. Working with governments, donors, non-governmental organizations, the private sector, and health agencies, MSH responds to priority health problems such as HIV & AIDS; tuberculosis; malaria; maternal, newborn and child health; family planning and reproductive health; and chronic non-communicable diseases such as cancer, diabetes, and lung and heart disease. Through strengthening capacity, investing in health systems innovation, building the evidence base, and advocating for sound public health policy, MSH is committed to making a lasting difference in global health.
Detailed Job description / requirements:
Senior Technical Advisor - Regulatory Systems Strengthening
The goal of the global five-year USAID Medicines, Technologies and Pharmaceutical Services (MTaPS) Program is to help low- and middle-income countries to strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and pharmaceutical services. MTaPS, implemented by Management Sciences for Health (MSH) and partners, will provide technical assistance to the Ministry of Health and Population (MOHP) and the Department of Drug Administration (DDA) to strengthen pharmaceutical systems including pharmaceutical sector governance, good pharmacy practices, regulatory systems, pharmaceutical management information systems, and improve patient-centered pharmaceutical services.
The Senior Technical Advisor – Regulatory Systems Strengthening (RSS) provides technical assistance to the DDA and MOHP to build capacity and strengthen fundamental medicines regulatory processes and management information systems including development/updating of relevant policy documents, standard operation procedures and guidelines, medicines products and health technologies regulation and registration, inspection of wholesalers implementing good distribution practices and strengthening the implementation and use of Pharmadex, a regulatory electronic information management system.
Key Performance Areas
Technical Support (40%)
- Prepare and deliver technical presentations on key project activities and achievements as needed.
- In coordination with relevant partners, provide technical assistance to DDA to strengthen institutional and individual capacity, management systems, and governance of regulatory functions and activities at national and provincial levels.
- Support DDA to review and strengthen pharmaceutical regulatory systems including registration processes, structure and tools, through continuous quality improvement approaches.
- Guide and supervise the technical advisor on medical devices to strengthen health technology and, medicines and medical devices regulation and listing
- Support DDA in the implementation of a regulatory management information system, i.e., Pharmadex, to strengthen the regulation and registration processes for products, manufacturers, wholesalers, importers and pharmacies, pharmacovigilance, import and export system and inspection system. Strengthen information use and reporting based on Pharmadex
- Guide and supervise the technical advisor on pharmaceutical management information system to strengthen regulation, registration, inspection and data use in DDA.
- In collaboration with other partners, support DDA to review its operational processes including regulatory aspects to improve licensing and inspection of wholesalers and implementation of good distribution practices, and enforcement systems and tools.
Capacity Building (30%)
- Contribute to the design, implementation and monitoring of capacity building activities for DDA and MOHP included in the MTaPS Nepal workplan.
- Work with relevant partners to build sustainable capacity to implement good distribution practices, good review practices and strengthen product registration and regulation aligned with the World Health Organization (WHO) best practices.
- Carry out additional responsibilities as may be assigned from time to time.
Coordination and management (30%)
- Work closely with the MTaPS Nepal Management Team and the Finance and Administration Manager to develop and monitor appropriate/adequate budgets to support relevant technical activities.
- Report regularly to the Country Program Director on progress/results achieved in technical work plans and barriers encountered, and resolve any challenges faced.
- Take active part in minutes and report writing, development of success stories, technical briefs and work planning
- Represent the program at various technical meetings with other cooperating agencies and participate in various working groups as required, including making technical presentations on key activities and achievements of assigned areas as needed.
- Maintain close liaison and coordination with senior officials in the MOHP and DDA and other key stakeholders e.g. WHO, USAID implementing partners, to ensure technical assistance activities are carried out with their active participation for building ownership.
- Work closely with other MTaPS team members to ensure technical work plans are being implemented in a timely and technically sound manner, and productively leverage collaboration with key government and other stakeholders and partners.
REQUIRED MINIMUM EDUCATION
- Master’s Degree in pharmacy, medicine or related field with good understanding of medical products regulation.
REQUIRED MINIMUM EXPEREINCE
- At least 5 years of relevant experience in areas of medical products regulation and product registration, including medicines registration and medical devices listing.
- Demonstrated experience in regulatory affairs specifically medical products registration and regulatory inspections in low- and middle-income countries.
- Knowledge of international regulatory ecosystem, registration and inspection guidelines (e.g., WHO, ICH, PIC/S, EMA, ICH, FDA, GHTF, ISO, etc.)
- Demonstrated experience in development and implementation of GDP to maintain quality and integrity of products throughout the supply chain.
- Demonstrated experience in information management systems use and reporting
KNOWLEDGE AND SKILLS
- Strong knowledge and understanding of regulatory systems including health systems of low and middle-income countries preferably Nepal and other Southern and Southeast Asian countries
- Strong organizational skills and ability to work in a team-oriented, culturally diverse environment.
- Excellent interpersonal skills, sound judgment, communication skills, training experience, ability to identify and resolve policy, technical and operational constraints.
- Experience and ability working with senior government officials.
- Experience with USAID and other donor agencies desirable.
- Excellent written and verbal communication and presentation skills in English.
- Ability to prepare and review reports, SOPs, training materials, documents and presentations.
- Ability to design and conduct knowledge and skill-building training and workshops.
- Demonstrated advanced skills in Microsoft Office Suite applications, including Word, Excel, and PowerPoint. Familiarity with project management tools is a plus.
- English and Nepali fluency required including speaking, writing, and reading; additional proficiency in other Nepalese language is a plus.
- Functional competencies: highly motivated, resourceful, results driven and persistent. Ability to think strategically, gather and analyze information in order to make appropriate decisions. Strong interpersonal and communication skills.
- Core MSH competencies: adaptability, communication, problem solving, creativity and innovation, timeliness of work, quality of work and team relationships, resource utilization.
- Sound judgment, self-motivated, interested in information technology and strong initiative
- Ability to travel in-country to support technical activities.
- Keyboard use, pulling drawers, lifting papers <10 lbs., etc.
MSH is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender or gender identity, religion, creed, citizenship, national origin, age, veteran status, or disability unrelated to job requirements. MSH will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, MSH has developed and maintains an affirmative action program and plan.