长沙招聘

Job Description

?      Take charge of Regulatory Intelligence for Drug relevant, and as a RA contact person to consolidate Medical Device related policies. To Share and interpret policies to internal stakeholders.

?      As a RA contact person to drive the regulatory input and support on assigned projects ICFC (In China For China), as well as some Generic Quality Consistency Evaluation projects.

?      Work closely with the relevant stakeholders including PMO, BD, R&D, MA, Commercial, etc.

?      Lead new project RA assessment if needed.

Responsibilities:
Being a RA Manager, the professional in this position will fulfill regulatory responsibilities including but not limited to the following:

1.          Key contact person as Regulatory Intelligence internally and externally

2.          Project driven, establish a thorough submission plan with strategic thinking for each assignment within the timeline agreed by stakeholders;

3.          Obtain timely approval for new drugs and all other necessary approvals for the existing products maintenance.

4.          Ensure regulatory/legal compliance of regulatory activities.

5.          Liaising with the relevant governmental bodies and regulatory authorities, such as NMPA, CDE, NIFDC, etc..

Qualifications:

1.          Bachelor degree or above, major in pharmaceutical or related major;

2.          At least 7 years of experience in pharmaceutical industry;

3.          Excellent knowledge and competency in Drug registration and relevant technical guidelines.

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.