PQM+ Asia Bureau is collaborating with key stakeholders in the Association of Southeast Asian Nations and the South-East Asia Regulatory Network to promote regional medicine regulatory convergence and reliance to improve regulatory systems and assure the quality of medical products in the region. In this regard, PQM+ Asia Bureau is implementing several activities, including regional and country-targeted workshops to assist the development of regional and country-specific action plans and training of trainer courses in marketing authorization-related topics, among others.
In the Philippines, PQM+ is assessing the country’s readiness to optimize and expand the local production and supply of essential health products. A key focus of PQM+ is to help foster an enabling environment that encourages private sector investment in the pharmaceutical sector. A strong domestic and export pharmaceutical industry confers numerous economic and public health benefits for a population. Not only will this bolster the economy in terms of the resulting foreign exchange, but it will also ensure the provision of safe, effective, and quality assured drugs in the country.
The PQM+ Asia Bureau team is seeking a Regulatory Systems Strengthening Philippines-based Consultant to contribute to the successful implementation of the program. The consultancy is on an “as-needed basis” (approx. weekly 20-30 hours) and has a performance period through September 30, 2024, with the option of getting extended based on the activities’ implementation timeline.
Key Responsibilities
1. Coordinate with regulatory authorities, country stakeholders, including international agencies and donors, and the PQM+ Asia Bureau team to design logical frameworks and action plans to strengthen national regulatory systems in their respective countries. In the Philippines, key stakeholders include but are not limited to the Food and Drug Administration of the Philippines, the Department of Health, pharmaceutical associations, manufacturers, World Health Organization (WHO), and USAID implementing partners.
2. In line with the PQM+ Asia Bureau annual work plan, lead or contribute to in-country implementation with support from regional and global program teams.
3. Facilitate or participate in regulatory system strengthening discussions, brainstorming sessions, and capacity building events at country and regional levels.
4. Support the development of presentations and technical reports with practical recommendations for policy initiatives and regulatory reform to promote local production of priority medicines.
5. Contribute to the design of qualitative tools (e.g., questionnaires) to identify strengths, weaknesses, gaps, or regulatory challenges and competencies to determine technical assistance needed to foster local production of essential medicines of high public health importance in emergencies and unmet medical needs.
6. Conduct desk review, including documentation, to identify key regulations, policies, and documents.
7. Supports program team in day-to-day country-level operational tasks to facilitate the implementation.
8. Supports logistics and operation tasks related to the implementation of country workshops, trainings, and meetings.
9. Other program-related tasks as assigned by the supervisor.
Required Qualifications
· Ten (10) years of national, regional, or international professional experience leading work in the area of regulation of medical products within the national or regional regulatory authority and pharmaceutical industry is required.
· Knowledge of regulatory systems strengthening and the WHO Global Benchmarking Tool (GBT) and methodology
· Previous working experience with national medicines regulatory authorities or UN agencies (e.g., World Health Organization, UNICEF)
· Bachelor’s degree in pharmacy, chemistry, public health, or a related subject. Master’s degree in a relevant field will be an added advantage.
· Strong interpersonal skills, with an ability to build relationships and interact effectively with country counterparts, technical experts, and donor agencies.
· Proven ability to meet deadlines and pay close attention to detail. Well-organized with demonstrated multi-tasking skills.
· Ability to work collaboratively as part of a multi-cultural team and independently to produce high-quality products.
· Strong written and oral communication skills.
Period of Performance
May- September 30, 2024. Additional consultancy available depending on satisfactory work performance by the consultant.
This position is for Philippines-based candidates. No relocation assistance will be provided.
Please send CV, contact information for three references, and hourly rate in USD to GPH_Procurement@USP.org by the closing date of May 14, 2024, at 05:00 PM EST. When submitting your application, write “RSS Consultant - Asia Region” in the email Subject Line.
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. By sharing scientific expertise and providing technical support and leadership, USP helps local regulators improve and sustain local health systems and enables manufacturers to supply quality-assured essential medicines for years to come.
In 2019, the United States Agency for International Development (USAID) awarded USP the Promoting the Quality of Medicines Plus (PQM+), a USAID-funded global program designed to sustainably strengthen medical product quality assurance systems in low- and middle-income countries.
