Regional Adviser (Medical Products Quality & Regulation)
: Feb 2, 2021, 9:50:14 PM
: Feb 25, 2021, 4:29:00 AM
: India-New Delhi
: SE/HSD Department of Health Systems Development
OBJECTIVES OF THE PROGRAMME
Access to quality medical products 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 viz medicines, vaccines, medical devices and diagnostics, enforcement of legal procedures related to medicines 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 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. Newer products are coming into the market and the role of the regulator is to ensure safe, efficacious and affordable products for their populations. The technical and managerial capacities of the regulatory agencies in member countries need to be strengthened for them to be able to effectively discharge their responsibilities.
Through the South-East Asia Regulatory Network (SEARN), by increasing collaboration, Member States in the Region have agreed to
1. enhance the ability of national regulatory authorities to ensure safety and quality of medical products;
2. develop more streamlined work sharing arrangements together to accelerate access to medical products.
The expected 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 including collaboration in regulation and more rational use of medicines with a focus on antibiotics.
DESCRIPTION OF DUTIES
Under the overall guidance of Director, Programme Management and direct supervision of Director, Health Systems Development (HSD), the incumbent will perform the following duties:
1. Provide technical guidance to countries for improving quality and regulation, and regulatory system strengthening for medicines, medical devices and diagnostics in the countries in the region;
2. Provide technical advice and support activities and deliverables of SEARN, including ways to expedite approval of new and existing priority products through inter-country collaboration and support for quality control laboratory network;
3. Support the organization of country self- and joint assessments of regulatory capacity, including supporting institutional development plans;
4. Promote engagement of external partners supporting national regulatory system strengthening, to align with national regulatory agency priorities and institutional development plans;
5. Support post-marketing surveillance and vigilance activities for medicines and medical devices in the SEARN network;
6. Develop and contribute to publications on quality and safety of medical products; and
7. Perform any other relevant duties assigned by Director HSD or supervisor.
Essential: Master’s level university degree in pharmacy/medicine/biochemistry/microbiology/biological sciences/bio-technology/public health or other health science-related field.
Essential: At least ten years’ relevant experience in the area of medical products, particularly pharmaceuticals regulation, some of which should have been obtained in an international context.
Good knowledge of product development, production and control. This includes having worked for a medicines 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.
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 88,162 (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 2439 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.