OBJECTIVES OF THE PROGRAMME
Access to quality medical products (medicines, vaccines, medical devices and diagnostics) is crucial for achieving universal health coverage (UHC) and in attaining the Sustainable Development Goals (SDG 2030). The goal of the Department of Health System Development is to support advances in UHC in SEAR Member States, to improve people's access to needed services and medical products without suffering financial hardship. Medical products regulatory agencies are tasked to ensure the safety, quality and efficacy of all medical products, medicines, vaccines, medical devices and diagnostics, enforcement of legal procedures related to drug development and manufacturing, monitoring and ensuring compliance with statutory obligations. The regulatory agencies play an essential role in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection. Regulators face a number of challenges today and these are related to the wide variety of medical products that they must deal with (medicines, vaccines, diagnostics and medical devices). Newer products are coming into the market and the role of the regulator is challenging to ensure safe, efficacious and affordable products for their populations. Through SEARN, by increasing collaboration, Member states in the Region have agreed to
- enhance the ability of national regulatory authorities to ensure safety and quality of medical products;
- develop more streamlined work sharing arrangements together to accelerate access to medical products;The result is people across the Region will have access to safer and better-quality medical products.
This is a priority within the WHO's new General Programme of Work.The South-East Asia Region has five priorities for improving access to quality medical products: collaboration in regulation; greater capacity to work within intellectual property and trade rules and use TRIPS flexibilities; collaboration on pricing and procurement; more rational use of medicines with a focus on antibiotics, and improved monitoring of access to medical products.
DESCRIPTION OF DUTIES
- Summary of Assigned Duties (Describe what the incumbent has to do to achieve main objectives; include main achievements expected):Under the overall guidance of Director, HSD and direct supervision of Regional Adviser, Intellectual Property Rights, Trade and Health (IPT), the incumbent will perform the following duties:
- Support activities and deliverables of the South-East Asia Regulatory Network (SEARN), including ways to expedite approval of new and existing priority products through inter-country collaboration and support for quality control laboratory network.
- Provide technical and managerial support for medical products (medicines, vaccines, medical devices and diagnostics) on regulation and regulatory system strengthening in the countries in the region
- Provides policy and technical support to Member countries in all aspects of vaccine supply management quality control and safety within the scope of Expanded Programmes on Immunization (EPI) and ensures technical quality of Vaccine Supply and Quality (VSQ) team activities.
- Facilitate the organization of country self- and joint assessments of regulatory capacity, including supporting institutional development plans.
- Promote engagement for defining roles and responsibilities for external partners supporting national regulatory system strengthening, to align with national regulatory agency priorities and institutional development plans.
- Support post-marketing surveillance and vigilance activities for medical products in the SEARN network
- Develop and contribute to publications on access to medical products.
- To perform any other relevant duties assigned by Director HSD or supervisor.
- Essential: Master's level university degree in pharmacy, medicine, biochemistry, microbiology, biological sciences, public health or other health science-related field.
- Desirable: Advanced degree or specialization in the manufacture, production or regulation of one or more medical products (medicines, vaccines, diagnostics, devices)
- Essential: At least seven years of experience in medical product regulation, some of which should have been obtained in an international context
- Desirable: Experience in working on medical product regulation in a low or middle-income countryExperience in working across multiple agencies and managing their often-diverse objectives.
- Good knowledge of product development, production and control. This includes having worked for a medicines/vaccines manufacturer or a national regulatory authority. Demonstrated ability to work with experts at national and regional levels, and to establish and maintain effective working relationships with people of different national and cultural backgrounds. Excellent organizational skills.
- Other Skills (e.g. IT): Proficient in MS Office Software applications, data analysis and technical presentations.
- Respecting and promoting individual and cultural differences
- Ensuring the effective use of resources
- Producing results
Use of Language Skills
- Essential: Expert knowledge of English.
WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 73,516 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 2016 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.