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无工作经验 -
招1人 -
11-09 发布
- 五险一金
- 绩效奖金
- 定期体检
职位描述
职位描述： 工作职责：?Utilize regulatory expertise to review, develop and deliver labeling documents such as the LPD, LLD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting advice or input from other functions when appropriate.?Production of other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supportive documentation.?The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as other complex revisions.?For deliverables in scope, support responses to inquiries from Pfizer colleagues in response to inspection activities and may provide support during regulatory agency questions.?May coordinate labeling revisions when there is a regional, global or therapeutic area impact across multiple countries?May mentor or train more junior labeling managers in their day-to-day activities?Ability to run training and awareness sessions on labeling processes and ability to clearly articulate expectations of the labeling process to stakeholders.?Takes appropriate risks to advance new concepts and methodologies that are moderately complex, participating in pilots as directed and other continuous improvement projects.?Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.?Meets defined targets on productivity, quality and compliance, as set by and overseen by management.?Meets strategic targets for labeling deliverables as defined for the function, and communicates progress against these targets or issues which affect these targets, and proposes remediation.任职资格：?Has thorough knowledge of the principles, concepts and theories of labeling, and awareness of principles and concepts of other labeling-related disciplines.?Understands and applies labeling regulation knowledge in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text.?Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures?Fluency in English language important however multi-language skills are advantageous?Written and verbal communications clear and effective?Understands and applies labeling regulation in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text?Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverablesEducation:?Life sciences, pharmacy graduate or equivalent?Advanced academic qualifications/degree such as PhD an advantage but not essentialExperience:?Significant ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a CDS on LPDs?Proven ability to successfully understand regulatory implications of product strategy with regard to the produce label, assessment and practical management of associated impacts.?Demonstrated ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages?Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.?Knowledge of global/regional regulatory guidelines and requirements important?Knowledge of Clinical Variations preferred?Proven strength in logical, analytical and writing ability essential?Readability Testing knowledge an advantage but not essential?Demonstrated project management, attention to detail and problem solving skills required. 职能类别： 药品注册
联系方式
北京
公司信息
辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球最大的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。 我们的目标是“ ”。我们的使命是“ ”。 2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。 目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。 在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。 辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。 辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。 辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。 At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.
