Regulatory Affairs Manager 北京

月薪： 6-8千/月

该公司所有职位
  • 无工作经验
  • 招若干人
  • 11-09 发布
  • 体检

职位描述

职位描述： 工作职责Position PurposeThe Sr. Regulatory Affairs Manager is responsible for the regulatory maintenance of portfolio products and regulatory approval of new products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial approvals. The SRAM is also responsible for the specific registration projects to ensure that each project operates within the set timeframes and conducts in accordance with local regulatory agency requirements and relevant Pfizer SOPs.Supervising and coaching subordinates if necessary; Build up strong relationship with relevant government agency and keep closely contact with corporate supporting teamThe role will take a special focus on multiple therapeutic area designated to him to her. This will require the SRAM to maintain a global overview of the therapeutic areas, in respect of the Company’s products, competitor products and treatment standards. Thus providing this expertise to the clinical develop and medical group as well as to other Company personnel where required.Ensure optimal regulatory compliance in China.Primary ResponsibilitiesCollaborate and Communicate with China GEP and GIP President on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:1.New Drug and Inline Products Registration Planning & Implementing for the therapeutic area of AI products.1.1 Set up new product registration plan, prepare the regulatory submissions for registration of new products, variations and renewals to marketed products and clinical trial applications, where required1.2 Critically analysis data packages for regulatory compliance and identify discrepancies in data presented and request additional data1.3 Develop an overall perspective plan of registration projects1.4 Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes1.5 Maintain and update the Local Product Document (labeling) in accordance with relevant regulations and PPG SOPs1.6 Maintain an up to date knowledge of the relevant legislation in China1.7 Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products1.8 Provide regulatory advice to company personnel as required1.9 Partner with the global regulatory and clinical development team in GIP/GEP BUs for new products development strategy and inline products strategy.1.10 Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.1.11Partner with PGS for supply strategy to avoid supply issue due to site changes1.12 Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices2 Build-up Relationships with Both Relevant Government Agencies and Corporate Supporting Teams, Ensure Compliance with the Regulations and Expedite Approvals2.1 Well understand regulations and build up a platform to communicate with officials2.2 Provide necessary and timely supports to policy team for all the policy advocacy activities2.3 Efficiently use company resource to enhance the working relationship with relevant government agencies and building strong company image2.4 Actively collect information and monitor the change of regulatory environment;2.5 Strengthen the liaison with corporate support teams via various tools or communication channels during daily operation3 Ensuring Regulatory Compliance3.1 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 sites3.2 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 change4 Special Projects4.1 Be required to participate on special projects for the Regulatory Affairs Group5 Marketing Support5.1 Attend Regulatory Affairs Department, new product development , Medical and other internal meetings as required5.2 Provide a resource or supports for other sections of the company for specified therapeutic areas6 People Management & Team Work Spirit6.1 Demonstrate and influence the team on leadership behavior and core value in daily work, in terms of coaching and developing people; information/ best expertise sharing; positive and constructive way of communication (frank, honest, friendly etc)6.2 Ensure effective communications between Regulatory Affairs Department and other functional teams within company.7 Personal Development7.1 Complete the Pfizer PRE Safety Reporting Process: Overview training module in the set timeframe7.2 Attend and actively participate in personal development courses as required7.3 Attend training in specific therapeutic areas as required.7.4 Lead Regulatory Affairs, Clinical development and Medical Department projects and workshopsTechnical Skill Requirements1.Ability Functional 1.1 Organizing and planning1.2 Communication and interpersonal skill1.3 Team spirit1.4 Good sense in the area1.5 Problem solvingComputer skill2.Cultural Competencies (Leader Behaviors)2.1Sustain Focus on Performance2.2Create an Inclusive Environment2.3Encourage Open Discussion and Debate2.4Manage Change2.5Develop PeopleAlign Across Pfizer任职资格Qualifications (i.e., preferred education, experience, attributes)． Educational /TrainingBachelor degree or above in Pharmaceuticals, Pharmaceutical chemistry, Medical, Biologic or related sciences with a pharmaceutical major2．Working Experiences2.1 At least 8 years experience in Chinese regulatory affairs working at a high level of competency2.2 Independently lead a team with multiple therapeutic areas for at least 2 years2.3 Experience in more than one therapeutic areas2.4 Good working knowledge of international and local regulatory guidelines and codes.2.5 Fluent in English both in written and speaking, Proficiency in basic computer skills including Basic Microsoft Word, PowerPoint and Excel and familiarity with use of databases. 职能类别： 药品注册

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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.

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