Regional CMC Strategist
惠氏制药有限公司-健康药物部
- 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 快速消费品(食品、饮料、化妆品)
职位信息
- 发布日期：2015-06-17
- 工作地点：上海
- 招聘人数：若干
- 语言要求：英语熟练
- 职位月薪：面议
- 职位类别：生物工程/生物制药
职位描述
Role Description:
? The CMC Regulatory Strategist will evaluate and develop filing strategies for CMC changes that may have regulatory impact on Pfizer Consumer commercial products marketed in China and other APAC countries. The CMC Regulatory Strategist will also author CMC submission content to support new registrations and variations to Marketing Authorizations for Modules 2 and 3 using Common Technical Document (CTD) format.
? The incumbent will work closely with technical groups within Pfizer Global Services (PGS) to ensure that GMP-related documentation is complete and appropriate for the disposition of product change requests (PCRs) and product change proposals (PCPs), and authoring of submission ready components (SRCs). The colleague will also liaise with personnel within the GCMC Regional Regulatory CMC Conformance Hubs, Worldwide Regulatory Strategy (WRS), WSRO (Worldwide Safety and Regulatory Operations) and PCOs (Pfizer Country Offices) to ensure right first time (RFT) delivery of filing strategies and submission packages within project timelines.
Responsibilities: Core responsibilities include but are not limited to,
? Assures that all impacted products, affected sites and markets are documented in the PCR, and that the attached site documentation meets requirements to fulfil SRC authoring requirements.
? Develops timely and right-first-time CMC filing strategies to support plant-based CMC changes changes initiated by Pfizer manufacturing sites and Contract Manufacturers, through the following stages of a product lifecycle:
? Introduction of a new commercial product, including new market introductions for existing products
? Post-approval changes
? License maintenance (ex. Renewals, annual reports, gap closures)
? Product withdrawals, discontinuation or divestment
? Initiates PCRs for certain change types (ex. Renewals, annual reports, gap closures)
? Authors accurate and complete submission ready components in China required format or CTD format (in English) according to project timelines. Prepares CMC sections using source plant GMP documentation (manufacturing control documents), within Pfizer GDMS Predict templates.
? Performs peer review and approval of submission components as part of review teams including, but not limited to, plant technical groups, QA, Regional CMC Conformance Hubs, WRS and PCOs.
? Prepares responses to queries from Health Authorities, and complies with requests for CMC information.
? Develops strong working relationships and acts as primary interface/point of contact with PGS and the Regulatory CMC Conformance Hubs.
? Ensures compliance with all applicable SOPs governing the Regulatory Change Management process.
? Documents and tracks progress of Health Authority commitments.
? Completes on-time delivery of metrics reports
? As directed by the GC3 Team Lead, may assume responsibility as a Product Strategist to provide guidance and input on cross-market CMC strategy for global products.
? Performs additional tasks as assigned by GC3 Management.
Qualifications (Training, Education & Prior Experience):
? Bachelors degree or above with a a minimum of 5-8 years of relevant experience in the healthcare and/or pharmaceutical industry is required.
? Minimum of 2-4 years of hands-on or exposure to CMC authoring experience for marketed products (initial registrations or post-approval variations) is required.
? Comprehesive knowledge of China regulations and CMC requirements on Consumer Healthcare Products/OTC products is mandatory.
? Comprehensive understanding of CTD format and content is highly desired
? Global regulatory experience (especially in APAC) with different Consumer submission types (drug, OTC, food, cosmetic, etc.) is highly preferred
? Experience working in the Pharmaceutical manufactuing industry (preferably QA, Technical Services, Operations, Manufacturing or R&D), knowledge of pharmaceutical development processes and cGMPs is required.
? Excellent English writing and oral presentation skills is mandatory.
? Prior experience with Consumer Healthcare Products highly desired
? Prior experience managing projects is preferred
? Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
? The CMC Regulatory Strategist will evaluate and develop filing strategies for CMC changes that may have regulatory impact on Pfizer Consumer commercial products marketed in China and other APAC countries. The CMC Regulatory Strategist will also author CMC submission content to support new registrations and variations to Marketing Authorizations for Modules 2 and 3 using Common Technical Document (CTD) format.
? The incumbent will work closely with technical groups within Pfizer Global Services (PGS) to ensure that GMP-related documentation is complete and appropriate for the disposition of product change requests (PCRs) and product change proposals (PCPs), and authoring of submission ready components (SRCs). The colleague will also liaise with personnel within the GCMC Regional Regulatory CMC Conformance Hubs, Worldwide Regulatory Strategy (WRS), WSRO (Worldwide Safety and Regulatory Operations) and PCOs (Pfizer Country Offices) to ensure right first time (RFT) delivery of filing strategies and submission packages within project timelines.
Responsibilities: Core responsibilities include but are not limited to,
? Assures that all impacted products, affected sites and markets are documented in the PCR, and that the attached site documentation meets requirements to fulfil SRC authoring requirements.
? Develops timely and right-first-time CMC filing strategies to support plant-based CMC changes changes initiated by Pfizer manufacturing sites and Contract Manufacturers, through the following stages of a product lifecycle:
? Introduction of a new commercial product, including new market introductions for existing products
? Post-approval changes
? License maintenance (ex. Renewals, annual reports, gap closures)
? Product withdrawals, discontinuation or divestment
? Initiates PCRs for certain change types (ex. Renewals, annual reports, gap closures)
? Authors accurate and complete submission ready components in China required format or CTD format (in English) according to project timelines. Prepares CMC sections using source plant GMP documentation (manufacturing control documents), within Pfizer GDMS Predict templates.
? Performs peer review and approval of submission components as part of review teams including, but not limited to, plant technical groups, QA, Regional CMC Conformance Hubs, WRS and PCOs.
? Prepares responses to queries from Health Authorities, and complies with requests for CMC information.
? Develops strong working relationships and acts as primary interface/point of contact with PGS and the Regulatory CMC Conformance Hubs.
? Ensures compliance with all applicable SOPs governing the Regulatory Change Management process.
? Documents and tracks progress of Health Authority commitments.
? Completes on-time delivery of metrics reports
? As directed by the GC3 Team Lead, may assume responsibility as a Product Strategist to provide guidance and input on cross-market CMC strategy for global products.
? Performs additional tasks as assigned by GC3 Management.
Qualifications (Training, Education & Prior Experience):
? Bachelors degree or above with a a minimum of 5-8 years of relevant experience in the healthcare and/or pharmaceutical industry is required.
? Minimum of 2-4 years of hands-on or exposure to CMC authoring experience for marketed products (initial registrations or post-approval variations) is required.
? Comprehesive knowledge of China regulations and CMC requirements on Consumer Healthcare Products/OTC products is mandatory.
? Comprehensive understanding of CTD format and content is highly desired
? Global regulatory experience (especially in APAC) with different Consumer submission types (drug, OTC, food, cosmetic, etc.) is highly preferred
? Experience working in the Pharmaceutical manufactuing industry (preferably QA, Technical Services, Operations, Manufacturing or R&D), knowledge of pharmaceutical development processes and cGMPs is required.
? Excellent English writing and oral presentation skills is mandatory.
? Prior experience with Consumer Healthcare Products highly desired
? Prior experience managing projects is preferred
? Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
公司介绍
惠氏曾是财富全球500强企业之一，也是全球最大的以研发为基础的制药和保健品公司之一，总部位于美国新泽西州的麦迪逊市。惠氏在探索、开发、制造和销售药品、疫苗、生物制品、营养品和非处方药品方面处于全球领先地位。惠氏的产品改善了全球各地人们的生活质量。
自上世纪80年代中期进入中国市场以来，惠氏在中国的业务发展取得了长足的进步。到目前为止，惠氏在华的业务已覆盖了处方药、非处方药和营养品三大领域。惠氏的品牌深受中国消费者的喜爱。
公司在***保健、神经系统、肌肉骨骼系统、心血管系统的治疗、疫苗和抗感染、血友病、免疫制剂和抗肿瘤等领域都有领先产品。惠氏的产品销售于140多个国家，正在改善全球千百万人的生活。惠氏每年投入约20亿美元用于研究和开发，正在开发的有60多种治疗性新药，创新药物在源源不断地推向市场，以保持其在业内领先的新药研发产品线。
惠氏现在已经是辉瑞的一部分。在不同的司法管辖地区，当地的惠氏与辉瑞的合并可能正在等待批准，该地区的合并有待按照当地法律法规的要求来完成。
作为辉瑞多元化业务之一的营养品部, 是研制营养品的先锋，所生产和销售的婴幼儿配方奶粉在国内同类市场中处于领先地位。
我们坚信：一个健康的世界源于健康的婴儿，我们的婴儿产品能为全世界提供最健康的保障。“惠氏”是“卓越、成就”的同义词，也是对全球健康的承诺的代名词，健康的世界始终是我们最重要的追求，宝宝的健康，我们的生命！我们，用制药的经验制造奶粉！
随着中国市场的快速发展和在全球战略中起到的日益重要的作用，公司将进一步加大在中国的投入和发展力度。最新的重点市场项目招聘已经启动！如果你有激情，有理想，勇于面对挑战，请加入我们；如果你想尝试新的销售领域，积累更多区域扩张的经验，请加入我们！
作为惠氏全球的优秀一员，惠氏健康药物部是世界上名列前茅的非处方药公司，旗下品牌覆盖了止痛、感冒咳嗽和维生素矿物质补充剂等众多领域。三个品牌居全球十大OTC品牌之列。
卓越的产品品质不仅赢得了众多消费者的认知，先进的研究与开发水平在改善人类生活品质方面更是享有盛誉，其骄人的销售业绩也在全球遥遥领先。
在中国，惠氏健康药物部成立于1991年。经过不断的努力，惠氏健康药物部不仅在中国OTC领域取得了领导地位，而且还在中国消费者心目中赢得了良好的品牌声誉。
目前，惠氏健康药物部销售的产品包括维生素矿物质补充剂和感冒咳嗽药两大产品。并且在进入全国医保目录的基础上，进入了绝大多数省市的医保目录。
一经录用公司将提供优厚的报酬，良好的福利及各种培训发展机会，请有意者于见招聘广告一周内将中英文简历、身份证、学历复印件、近照一张寄至各地人力资源部，或者请发送简历至指定邮箱(请在简历中或邮件中注明期望工资，并务必在信封左下角或邮件主题中注明应聘职位、城市)。
应聘职位地点：上海、杭州、常州、南京、苏州、徐州、福州、南昌、绍兴、温州、淮安、丽水、潍坊、烟台、镇江、宁波、苏州、南通、青岛、济南、湖州、芜湖、台州、无锡、扬州、嘉兴、舟山、济宁、武汉
地址：上海市南京西路1168号中信泰富广场26楼
邮政编码：200041
联系人：人力资源部（健康药品部）
应聘职位地点：广州、佛山、中山、湛江、福州、泉州、厦门
地址：广州市环市东路362-366号好世界广场22楼
邮编：510060
应聘职位地点： 成都、重庆、昆明、贵阳、西安、兰州、乌鲁木齐
地址： 成都市总府路2号时代广场A座705B
邮编： 610016
联系人： 人力资源部
E-mail： chinahrwest@pfizer.com
自上世纪80年代中期进入中国市场以来，惠氏在中国的业务发展取得了长足的进步。到目前为止，惠氏在华的业务已覆盖了处方药、非处方药和营养品三大领域。惠氏的品牌深受中国消费者的喜爱。
公司在***保健、神经系统、肌肉骨骼系统、心血管系统的治疗、疫苗和抗感染、血友病、免疫制剂和抗肿瘤等领域都有领先产品。惠氏的产品销售于140多个国家，正在改善全球千百万人的生活。惠氏每年投入约20亿美元用于研究和开发，正在开发的有60多种治疗性新药，创新药物在源源不断地推向市场，以保持其在业内领先的新药研发产品线。
惠氏现在已经是辉瑞的一部分。在不同的司法管辖地区，当地的惠氏与辉瑞的合并可能正在等待批准，该地区的合并有待按照当地法律法规的要求来完成。
作为辉瑞多元化业务之一的营养品部, 是研制营养品的先锋，所生产和销售的婴幼儿配方奶粉在国内同类市场中处于领先地位。
我们坚信：一个健康的世界源于健康的婴儿，我们的婴儿产品能为全世界提供最健康的保障。“惠氏”是“卓越、成就”的同义词，也是对全球健康的承诺的代名词，健康的世界始终是我们最重要的追求，宝宝的健康，我们的生命！我们，用制药的经验制造奶粉！
随着中国市场的快速发展和在全球战略中起到的日益重要的作用，公司将进一步加大在中国的投入和发展力度。最新的重点市场项目招聘已经启动！如果你有激情，有理想，勇于面对挑战，请加入我们；如果你想尝试新的销售领域，积累更多区域扩张的经验，请加入我们！
作为惠氏全球的优秀一员，惠氏健康药物部是世界上名列前茅的非处方药公司，旗下品牌覆盖了止痛、感冒咳嗽和维生素矿物质补充剂等众多领域。三个品牌居全球十大OTC品牌之列。
卓越的产品品质不仅赢得了众多消费者的认知，先进的研究与开发水平在改善人类生活品质方面更是享有盛誉，其骄人的销售业绩也在全球遥遥领先。
在中国，惠氏健康药物部成立于1991年。经过不断的努力，惠氏健康药物部不仅在中国OTC领域取得了领导地位，而且还在中国消费者心目中赢得了良好的品牌声誉。
目前，惠氏健康药物部销售的产品包括维生素矿物质补充剂和感冒咳嗽药两大产品。并且在进入全国医保目录的基础上，进入了绝大多数省市的医保目录。
一经录用公司将提供优厚的报酬，良好的福利及各种培训发展机会，请有意者于见招聘广告一周内将中英文简历、身份证、学历复印件、近照一张寄至各地人力资源部，或者请发送简历至指定邮箱(请在简历中或邮件中注明期望工资，并务必在信封左下角或邮件主题中注明应聘职位、城市)。
应聘职位地点：上海、杭州、常州、南京、苏州、徐州、福州、南昌、绍兴、温州、淮安、丽水、潍坊、烟台、镇江、宁波、苏州、南通、青岛、济南、湖州、芜湖、台州、无锡、扬州、嘉兴、舟山、济宁、武汉
地址：上海市南京西路1168号中信泰富广场26楼
邮政编码：200041
联系人：人力资源部（健康药品部）
应聘职位地点：广州、佛山、中山、湛江、福州、泉州、厦门
地址：广州市环市东路362-366号好世界广场22楼
邮编：510060
应聘职位地点： 成都、重庆、昆明、贵阳、西安、兰州、乌鲁木齐
地址： 成都市总府路2号时代广场A座705B
邮编： 610016
联系人： 人力资源部
E-mail： chinahrwest@pfizer.com
联系方式
- Email：chinahrwest@pfizer.com