Regulatory Affairs Manager(J24140)社

面议

市辖区本科及以上7年及以上

发布时间：2023-09-06

职位描述

工作职责:
The Regulatory Affairs Manager assists with the regulatory maintenance of a portfolio of products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial notifications, when required. The Regulatory Affairs Manager will assist the line Managers on specific projects, and in some instances will be responsible for their own projects. The Regulatory Affairs Manager ensures that each project operates within the set timeframes, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Pfizer Standard Operating Procedures. The Regulatory Affairs Manager may also be required to assist on special projects for the Regulatory Affairs Group. Ensure optimal regulatory compliance in China.
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 practices
II. 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 change
任职资格:
QUALIFICATIONS / SKILLS
Education
Tertiary qualifications in pharmacy or a science degree with a pharmacology major.
Experience
At least 6 years experience in regulatory affairs working.
Technical
Good working knowledge of international and local regulatory guidelines and codes
Proficiency in Basic Microsoft Word, PowerPoint and Excel
Ability Functional
Organizing and planning
Communication and interpersonal skill
Team spirit
Good sense in the area
Problem solving

其他要求

招聘人数：1人
职能类别：

公司介绍

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。