J&J Family of Companies RA Specialist-Transformation in Beijing, China

Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Organizes and maintains reporting schedules for new drug application and investigational new drug applications. Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope of complexity. Conducts searches of existing files for requested information. Maintains and archives all regulatory documentation.

Qualifications

Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Organizes and maintains reporting schedules for new drug application and investigational new drug applications. Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope of complexity. Conducts searches of existing files for requested information. Maintains and archives all regulatory documentation.

Primary Location

China-Beijing-Beijing

Organization

Johnson & Johnson Medical Shanghai Ltd. (7055)

Job Function

Regulatory Affairs

Requisition ID

1700187123W