Senior RA Manager
Bristol Myers Squibb
Beijing, CN
2天前
source : DirectEmployers Association

Bristol-Myers Squibb is a global Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Take the responsibility for implementing and delivering regulatory submission and approval and maintenance for products / projects within agreed timeline.

Ensure regulatory compliance with government policy and company required SOPs Establish and maintain close relationship with SFDA / CDE / NICPBP and other appropriate regulatory agencies and under manager's guidance have a close / effective communication with relevant regulatory agencies to consult regulatory strategy, determine status and facilitate the approvals of applications submitted to SFDA.

Conduct scientific discussion with relevant external and internal scientific functions locally and globally, specifically, global CMC and GRS Operation, Pharmaceutical Development, Pre-Clinical etc.

Maintain good knowledge in general / product specific scientific and regulatory requirement / process Maintain strong working relationship and communications with cross-functions to provide regulatory information and support.

Provide support to Policy & Intelligent management or Database development, update and maintain and training execution. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.

We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Company : Bristol-Myers Squibb Req Number : R1523734 SCN Updated : 2020-04-07 00 : 00 : 00.000 UTC Location : Beijing,China Bristol Myers Squibb is an equal opportunity employer.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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