J&J Family of Companies Associate RA Director, Robotics Ethicon-Beijing in Beijing, China

Manages the coordination, compilation and submission of new drug applications, abbreviated new drug applications and Investigational new drug applications to the regulatory agencies. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies. Provides guidance to project team members regarding regulatory compliance issues. Oversees the preparation and maintenance of regulatory submissions and files. Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products. Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters. Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.

资历

Manages the coordination, compilation and submission of new drug applications, abbreviated new drug applications and Investigational new drug applications to the regulatory agencies. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies. Provides guidance to project team members regarding regulatory compliance issues. Oversees the preparation and maintenance of regulatory submissions and files. Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products. Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters. Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.

主要地点

中国-北京-Beijing

组织

  • 强生(上海)医疗器材有限公司

工作

Regulatory Affairs

Requisition ID

1700182372W