北京招聘

公司是一家500强医药公司

1、Regulatory compliance support for Quality Management System building

2.Labelling End to End labelling process optimization and operation excellence to support new product launch acceleration and marketed products compliance

3.Regulatory process development & resource planning

4.Regulatory compliance oversight and support for Quality Management System building, including development of RA compliance plan and quality metric, and contribution to quality system of Business quality, R&D quality, Site quality and others

5.Drive internal regulatory process development to reflect internal process and external legislation change, including labelling E2E process optimization, to reflect regulatory environment change, business model changes, and to mitigate identified gaps.

6.Driving system compliance and data accuracy, including new system launch readiness.

7.Leading China RA record Management, to ensure timely record archiving and retention, to support product LCM

Credo based behavior with regulatory

Qualifications & Competencies:

1、A bachelor degree major in chemistry, pharmaceutics, biology or a related life-science discipline. A master degree or above is preferable.

2.Minimum of 2 years’ experience in a multinational pharmaceutical company, relevant compliance management working experiences is preferable.Strong oral & written communication skill;

3.good leadership capability and ability to work under pressure. Demonstrated ability to effectively manage.

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