长沙招聘

工作职责:

Collaborate and Communicate with China PBG President on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:

I. Responsibilities

Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, where required.

Critically analyze data packages for regulatory compliance and identify discrepancies in data presented and request additional data.

Develop an overall perspective of registration projects.

Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes.

Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals.

Maintain and update the Local Product Document (labeling) and Artwork in accordance with relevant regulations and PPG SOPs

Maintain an up to date knowledge of the relevant legislation in China.

Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.

Provide regulatory advice to company personnel as required.

Partner with the global regulatory and clinical development team in China PBG BUs for new products

development strategy and inline products strategy.

Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.

Partner with PGS for supply strategy to avoid supply issue due to site changes

Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practicesII. Ensuring Regulatory Compliance

Ensure timely communicate  the requirement of CHP and other China regulations to PGS  QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites

Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and  specification/manufacture process changeIII. Special Projects

Be required to participate on special projects for the Regulatory Affairs GroupIV. Market Support

Attend Regulatory Affairs, Medical Department and other internal meetings as required.

Provide a resource for other sections of the company for specified therapeutic areas.V. Personal Development

Complete related Training.

Attend and actively participate in personal development courses as required.

Attend training in specific therapeutic areas as required.

Participate in Regulatory Affairs and Medical Department projects and workshops

任职资格:

Experience

At least 3 years experience in regulatory affairs working.

Technical

Strong Customer focus sense

Excellent communication & interpersonal skills

Excellent Teamwork/collaboration

Result orientated

Quality orientation

Excellent ability to research information

Able to work under pressure in a busy environment

Good working knowledge of international and local regulatory guidelines and codes

Good working knowledge of Microsoft Word, PowerPoint and Excel

Excellent English skill in speaking, reading and writing

Managerial

Cultural Competencies (Leader Behaviors)

Sustain Focus on Performance

Create an Inclusive Environment

Encourage Open Discussion and Debate

Manage Change

Develop People

Align Across Pfizer

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.

Collaborates with Midical, MI, CTM, Clinical Pharmacology, Clinical Development, Clinical Statistics, Safety etc.

RESOURCES MANAGED

Summary of resources managed.

May supervise contracted resources and external consultants on specific projects.

May have matrixed role on specific projects.

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。