长沙招聘

职位描述：
岗位职责:

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

What You’ll Be Doing
It’s impossible to list everything you’ll do here because every day is different. But a few things are clear, you’ll:
Prepare & submit documents, deliver timetable for license granted.
Responsible for license maintenance including renewal, variation, PI, label etc.
Responsible for IVINA project.
Responsible for registration affaires of exported product.
Responsible for regulatory collection, analysis and implementation.
Support site audit
Responsible for variation assessment from plant (leverage Trackwise 8 when possible)
Support other departments such as bidding, market, PV etc.
Responsible for archiving registration dossiers(leverage BaxEdge or sharepoint)
Responsible for other tasks assigned by supervisor above and support GRA CMC related tasks
Develop and improve good relationship with the authorities and promote Baxter image.

任职资格:

Do you have what takes to build a career here?
[Qualifications]
Bachelor degree in pharmaceutical, chemistry, biological and related discipline.
At least 5 years working experience in a pharmaceutical company and at least 3 years pharm registration experience.
Be able to project implementation, can face challenge
Good communication skill, creative thinking, with teamwork spirit,
Good at English writing, reading and speaking.
Good Computer skill.

Why Baxter?
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

Apply today and experience a career that matters!

Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law.

http://jobs.baxter.com/ShowJob/Id/62263/Reg-Affairs-Spec-I/

百特国际有限公司提供肾科与医院关键产品的广泛组合，包括居家透析、急重症透析和中心透析产品；无菌静脉输液；输注系统与设备；肠外营养；生物外科产品与麻醉；以及药房自动化、软件和服务。公司凭借全球布局，以及其产品与服务的必需性，在提升新兴与发达国家市场医疗可及性方面发挥至关重要的作用。百特在全球的五万名员工，秉承公司在医疗创新领域的深厚积淀，持续推动未来的医疗创新，更好地满足患者的医疗需求。

Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.