Mgr, Regulatory AffairsReq # JR - 024400 Location Shanghai, Shanghai Municipality, China Additional Locations 40 Job Category Regulatory Affairs Date posted 07/22/2020
Are you looking for a career that matters?
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
Essential Duties and Responsibilities
- Establish a thorough submission plan with strategic thinking for each assignment within the timeline agreed by stakeholders;
- Obtain timely approval for new drugs and all other necessary approvals for the existing products maintenance.
- Ensure regulatory/legal compliance of regulatory activities.
- Liaising with the relevant governmental bodies and regulatory authorities, such as NMPA, CDE, NIFDC, etc..
- Regulations/ policies summary and some regulatory intelligence works as assigned.
- Bachelor degree or above, major in pharmaceutical or related major;
- At least 7 years of experience in pharmaceutical industry;
- Excellent knowledge and competency in Drug registration and relevant technical guidelines.
- Good communication skill, creative thinking, with teamwork spirit; Result and detailed oriented and able to work under pressure to meet tight timelines
- Good written and spoken English + Mandarin
- Good Computer skill.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.