长沙招聘

职位描述：
Core responsibilities include but are not limited to:
? Possess a high level of understanding of the technical/regulatory aspects and product characteristics that impact CMC regulatory strategy of assigned products
? Ensures CMC contents are accurately and completely prepared/authored to support:
o Introduction of a new commercial product, including new market introductions for existing products
o Post-approval changes
o License maintenance (ex. Renewals, annual reports, gap closures)
? Ensures that submission related deliverables are provided in accordance with project timelines.
? Participates in the review and approval of newly authored submission content
? Performs functions within the PDM (Product Dossier Manager) system for changes impacting the specific global portfolio of products under his/her responsibility.
? Develops and communicates regulatory strategies (product & project-level) that identify regulatory risks & mitigation strategies and align with development and/or commercial plans
o Balancing regulatory requirements, constraints and risk posture with WSR, PGS, & Consumer Business goals
o Leverage diverse GCMC expertise and experience (regionally and globally) to share and incorporate learnings into future CMC strategies & submissions
o Develop robust CMC/Regulatory strategies and submission plans that provide fit for purpose regulatory submissions that will deliver market approvals
o Communicate CMC strategies, regulatory risks and mitigation plans to PCOs in alignment with GCMC “One Voice” . Influence PCO/HA to adopt innovative CMC strategies, when needed
o Use in-depth knowledge of country-specific pre- and post-approval CMC regulations to identify, interpret and apply local CMC requirements, in assigned region
o identify country-specific/regional CMC requirements and opportunities to “bundle” changes to reduce PCO submission volume
o Identify, assess impact & proactively communicate changes to local regulations
o Ensure local submission plans and forecasts meet GCMC, WSR, & PGS objectives and requirements
? Interacts with PGS, WSR, WSRO and Commercial to ensure effective communication and management of regulatory information and documentation for regulatory conformance and Consumer product life cycle management.
? Identifies and escalates regulatory conformance issues to the appropriate Leadership
? Provides regulatory support and assistance to technical groups within the region or market.
? Provides assistance to special projects requiring CMC Regulatory input, including due diligence activities in business development opportunities.
? Drives and leads discussions related to queries from Health Authorities, ensuring completeness of responses within requested timelines, and compliance of additional CMC information requests.
? Where necessary, provides assistance to internal compliance audits and assists in developing appropriate responses and action plans to address audit observations.
? Fosters a culture of strong performance, assuring team objectives are met and in alignment with business goals.
? Participates in Operational Excellence initiatives to identify and implement continous improvement strategies; tracks and reports progress. Assists in the determination and sharing of best practices across the organization. 举报 分享

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***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“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
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.