Associate Registration Manager(J24131)社

面议

市辖区本科及以上4年及以上

发布时间：2023-09-06

职位描述

工作职责:
JOB INFORMATION
JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job.
The Associate Registration 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 Associate Registration Manager will assist the line Managers on specific projects, and in some instances will be responsible for their own projects. The Associate Registration 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 Associate Registration Manager may also be required to assist on special projects for the Regulatory Affairs Group. Ensure optimal regulatory compliance in China.
JOB RESPONSIBILITIES
Indicate the primary responsibilities critical to the job.
Collaborate and Communicate with China PBG President on the ways to help the country meet annual objectives of vaccine BU 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 Pfizer 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
III. Special Projects
Be required to participate on special projects for the Regulatory Affairs Group
IV. 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 the Pfizer PRE Safety Reporting Process: Overview training module in the set timeframe.
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:
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
Certifications
Certificates of Educational background and related training certificates.
Education
Tertiary qualifications in pharmacy or a science degree with a pharmacology major.
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.

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。