Bristol Myers Squibb Regulatory Sr. Specialist in BEIJING, China
Assist Regulatory manager for implementing and delivering regulatory submission and approval, and maintenance for new products / projects in assigned therapeutic area within agreed timeline.
Ensure regulatory compliance with government policy and company required SOPs
Establish and maintain close relationship with CFDA/ CDE/ NICPBP/ Shanghai FDA/ Shanghai DCI 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 CFDA.
Conduct scientific discussion under guidance of supervisor with relevant external and internal scientific functions locally and globally, specifically, Global and China Clinical Research, global CMC and GRS Operation, Pharmaceutical Development, Pre-Clinical, etc.
Maintain good knowledge on general/product specific scientific and regulatory requirement / process
Maintain strong working relationship and communications with cross-functions to provide regulatory information and support
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
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, disability or protected veteran status.