自贡 [切换城市] 自贡招聘自贡生物/制药/医疗器械招聘自贡药品注册招聘

(Sr.) Specialist, RA Strategy and Delivery

百特(中国)投资有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2019-05-27
  • 工作地点:北京
  • 招聘人数:1人
  • 工作经验:无工作经验
  • 学历要求:招1人
  • 语言要求:不限
  • 职位月薪:20-30万/年
  • 职位类别:药品注册

职位描述

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:

Follow regulatory operation procedure to standardize internal work flow;

Manage the implementation of GQP and create related local SOP and coordinate with GRA, ensure consistency of regulatory practices, procedures and standards for RA team;

Responsible for the device registration status update and dossier upload including the internal data systems regularly;

Establish and manage paper and electronic archives for all types of registration dossier, approval documents, and ensure good maintenance;

Set up training management system, Organize the related training and support the team for RA operation actions;

Collect and summarize the information from RA team per the request from line manager and GRA, coordinate within RA, GRA and other functions primarily at operation level for RA activities;

Responsible for RA Quality and Compliance and be focused on the efforts across Regulatory to increase the leverage and streamline the processes;

Provide RA comments and support which is assigned by line manager;

Assist to leader to prepare and arrange RA activities.

Renewal registration follow ups.

Do you have what takes to build a career here?

Bachelor’s degree or above in Pharmaceutical related discipline;

With minimum of 2 years’ work experience of regulatory / quality;

Sound basis of Regulatory / quality knowledge, strong project management skill;

Good English skill, both oral and written;

Excellent communication and interpersonal skills, self-motivation, creative thinking with teamwork spirit;

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.


职能类别: 药品注册

公司介绍

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.

联系方式

  • Email:TTA@baxter.com
  • 公司地址:杭州