位于北京市, c22的 6 个优质head of职位（正在招聘！）

Senior Manager, Regulatory Affairs, Onco
Takeda Pharmaceutical —北京市
R&D - GRA - Regulatory Affairs Manager - BJ
Sanofi —北京市
- 合同工
9天
Manager Key Account Pharmaceuticals & Healthcare
cargo-partner —北京市
快速申请
McQueen Client Advisor
Alexander McQueen —北京市
Sales Manager (China)
Swaarm Tech GmbH —北京市
快速申请
Senior Director, Corporate Communication, Greater China
Visa Information Systems (Shanghai) Co., Ltd., Beijing Branch —北京市

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R&D - GRA - Regulatory Affairs Manager - BJ
Sanofi —北京市
Experience Minimum 8 years of regulatory affairs experience in the pharmaceutical industry, with solid experience in China regulatory submissions.
9天

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Senior Manager, Regulatory Affairs, Onco

Takeda Pharmaceutical -
北京市

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职位详情

完整职位描述

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Accountabilities:

In accordance with the company’s product launch strategy and department’s work plan, take full responsibility of the product registration and application for approval and develop the plan by stage. Contribute to decision making on drug registration leading to minimal registration timeline. May lead a project team or initiative within department or cross-functions/divisions. Provides technical leadership to business. Summarize product registration related materials with coordination among head office, factory, Sales & Marketing. Provide corresponding support for the sales in China market. In accordance with the plan of product registration and application for approval, manage the necessary materials and information during the process and track and summarize the progress. Be responsible for submission of complete and qualified product application data to drug regulatory authorities, coordination of raw data review and on-site assessment. Manage and archive examination and registration materials and other relevant documents. Provide necessary support to the preparation and implementation of clinical trial. Establish influential relationships with key regulatory authority individuals and KOLs in relevant fields, such as SFDA, CDE, NIFDC, PIDC etc. Monitor regulatory environment and collect important information such as regulations, guidelines, competitive products etc. Establish and maintain internal/external channels of communication. Ensure regulatory activity is in compliance with authority and Takeda policy. Coordinate with the establishment of internal SOP and system. Others assigned by line manager.

Education & Competencies (Technical and Behavioral):

Level of Education: Bachelor’s degree or above majored in medicine or pharmacy.
Working Experience in Relevant Field: >7 years related work experience
Professional Knowledge and Skills: Skilled in using computer office software. Good English or Japanese in listening, speaking, reading and writing. Be familiar with the laws and regulations of drug administration and registration management, stronger professional competency, excellent communication skill and leadership. Teamwork and collaboration.

Locations

Beijing, China

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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Senior Manager, Regulatory Affairs, Onco

R&D - GRA - Regulatory Affairs Manager - BJ

Manager Key Account Pharmaceuticals & Healthcare

McQueen Client Advisor

Sales Manager (China)

Senior Director, Corporate Communication, Greater China

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在北京市, c22的head of个职位

R&D - GRA - Regulatory Affairs Manager - BJ

Manager Key Account Pharmaceuticals & Healthcare

McQueen Client Advisor

Sales Manager (China)

Senior Director, Corporate Communication, Greater China

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