Johnson & Johnson Careers

(Senior) RA Specialist-CERENOVUS

Beijing, Beijing
Regulatory Affairs


Job Description

Requisition ID: 1805661078W

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 preparation 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 preparation 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-Beijing-Beijing
Organization
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Regulatory Affairs
Requisition ID
1805661078W