长沙招聘

General Summary

• Provides technical knowledge and support of clinical trials applications, regulatory requirements for study start up, marketing-authorisation applications, and license maintenance for both internal customers and external clients related to drugs, biologicals and medical devices. Primary job responsibilities include the preparation of regulatory strategy/plan, the preparation and coordination of submissions to support clinical trial application, new drug application, abbreviated new drug application, supplemental applications, etc.

• Provide regulatory expertise to the products’ research and development.

• Supports business development efforts.

• Monitor and assess the regulations and regulatory trends for healthcare and pharmaceutical products.

• Participate in project teams and may lead specific regulatory tasks, under the guidance of senior staff.

• Response for direct communication of project specifics to external client upon the approval of senior staff.

 

Accountabilities

• Develops or reviews regulatory strategy and action plan for internal or external projects.

• Provides advises, consults in the area of expertise both internally and to clients.

• Prepares or reviews regulatory dossier and ensure timely submission, in compliance with regulations, guidelines and SOPs. Resolve any issue timely to ensure earliest possible registration.

• Keeps abreast of current data, trends, regulatory knowledge, developments and advances in the China and global regulatory environment. Ensure any potential impact to projects or company business have been thoroughly well communicated.

• Manages and coordinates resources and reviews workload for all direct reports. Guide and support staff to improve knowledge and skill continuously. Reviews performance and provide counseling for direct reports

• Provides support to Business Development

• Interacts with internal and/or external clients. Identifies and responds appropriately to issues, providing adequate and/or innovative solutions.

• Identifies project needs and scope of work, creates project timelines and implements client requests, seeking clarification and senior review, as necessary.

• Works with minimal direction, identifies project needs, creates project timelines, and tracks project budgets (where appropriate) for multiple projects and revises and manages scope of work changes, when necessary.

• May serve as Project Manager or technical lead on a regulatory project.

• Build up and sustain a reliable and professional relationship with regulatory authorities (e.g., CFDA, CDE, NICPBP, Provincial FDAs, Drug Control Institutes).

 

 

 

Qualifications

• Undergraduate degree or above in medical science or related life sciences area. Over 6 years of regulatory experience in a global leading pharmaceutical company or CRO.

• Ability to exercise independent judgment in developing effective resolutions to problems in a regulated environment.

• Must demonstrate abilities in scientific knowledge and its appropriate application to regulatory issues.

• Extensive knowledge of regulations relevant to the area of expertise.

• Ability to work on several projects at once while balancing multiple timelines (i.e., overlapping timelines on one or more projects).

• Ability to communicate effectively in both oral and written modes.

• Ability to communicate at multiple levels in the organization and in difficult situations.

• Must have careful attention to detail and accuracy.

• Open attitude and willing to meet challenges.

• Must possess strong negotiating skills.

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。