J&J Family of Companies Senior Regulatory Affair Specialist-RA-Suzhou in Suzhou, 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. Involved with the prepaAration of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. 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. Involved with the prepaAration of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new drug application and investigational new drug applications.

Primary Location

China-Anhui-Suzhou

Organization

Johnson & Johnson Medical Suzhou Ltd. (7054)

Job Function

Regulatory Affairs

Requisition ID

1700177014W