Johnson & Johnson Careers

Senior RA Manager

Beijing, Beijing
Regulatory Affairs


Job Description

Requisition ID: 1805650958W

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.
Qualifications

1.     Principal Duties and Responsibilities

-        Product registration related including new and renewal

·           Handling registration processes for Spine, including

n  Document requirement

n  Dossier preparation

n  Submit to CFDA

n  Follow up evaluation procedure

n  Sample ordering, type testing

n  Solve various problems in whole process

·           Ensure to obtain the regulatory permits on time, in support of the organization’s business requirements

·           Having a good and consistent communication with local marketing and known well the business plan especially product launch plan

·           Figuring out a rational working registration plan

·           Keeping all medical device relevant regulations in mind and having the own opinion on revision when necessary

·           To coordinate the post market surveillance and recall with the written explanation if happening

·           Working for product related copy review with the regulatory opinion

·           Support Chinese IFU and labeling for product related

-        Being proactive to participate the industrial activities to contribute the constructive suggestion

-        Paying attention to the market information such as the competitors’ with the analysis

-        Being involving into team working such as department meeting logistic arrangement

-        Bearing part of new employee orientation training

-        Maintain & input database like RA database, RTL…

-        Provide monthly report & analysis including latest registration status & post market surveillance.

 

 

2.     Requirements

-        Medical or related education background and knowledge

-        At least 5+ years Medical Device registration experience

-        Good communication skill

-        Better English and Chinese in writing and oral

-        Well computer operating

-        Good time management



Primary Location
China-Beijing-Beijing
Organization
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Regulatory Affairs
Requisition ID
1805650958W