J&J Family of Companies Assistant RA Manager, CER-RA-Beijing 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. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Develops timelines for submissions under the direction of senior regulatory affairs staff. Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables. Provides regulatory advice to project teams. Organizes and maintains reporting schedules for new drug application and investigational new drug applications.

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. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Develops timelines for submissions under the direction of senior regulatory affairs staff. Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables. Provides regulatory advice to project teams. Organizes and maintains reporting schedules for new drug application and investigational new drug applications.

Primary Location

China-Beijing-Beijing

Organization

Johnson & Johnson Medical Shanghai Ltd. (7055)

Job Function

Regulatory Affairs

Requisition ID

1700182369W