The Program Specialist serves as the Senior Specialist in the U.S. Food and Drug Administration (FDA) Office of Global Policy and Strategy (OGPS) China Office in Beijing, China. The Program Specialist monitors, analyzes, and prepares highly specialized reports on FDA regulated products (human and animal foods, dietary supplement, biologic products, drug, medical devices, and cosmetics), marketing and trade policy and provides expert strategic advice on complex decision-making on FDA regulated products with the objective of promoting public health through innovation and product safety, taking into consideration sensitivities related to the PRC. 


Responsibilities also include working with U.S. and Chinese government agencies and industries to resolve trade issues of non-compliance with U.S. and China import & export regulations, supporting FDA regulatory actions such as inspections and policy advocating and outreach, and strengthening the cooperation with Chinese regulatory authorities and industry officials by developing and maintaining key professional and social relationships (mid-to-high levels) with officials from central and local regulatory authorities, non-governmental organizations, universities, and the private sector.

Requirements:

EXPERIENCE: A minimum of 5 years of work experience in industry, and/or in governmental agencies with responsibility for regulatory policy issues or product safety and quality issues is required that includes extensive analysis and report writing on complex subjects. At least 4 of these years should involve work in either relations between government bodies and industries or in quality assurance programs or investigations. Demonstrated aptitude (practical and/or theoretical) in integrating programs with a wide range of stakeholders to promote product safety is required.

Education Requirements:

Master’s degree in Business Administration, Economics, Management, or in Medical, Public Health, Biological, Chemical or relevant engineering sciences is required.


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