宜昌招聘

岗位职责：

1、 参与新产品的前期注册分析、评估与规划、策略和计划制定并执行；Involve into the analysis, assessment and plan of new products at early stage, and develop the regulatory strategies and plan and implement it.

2、 组织项目管理团队，准备并完成沟通交流会议资料、临床试验申请资料、上市申请资料并提交；Organize the RA project team to prepare the brief documents for consultation meeting, IND documents and NDA documents, and submit;

3、 积极跟踪审评进度并与审评人员沟通，及时组织团队完成发补要求资料并取得批准；Actively follow up the review process, and communicate with the reviewers, and organize the team members to finish the replay report for deficiency letter, and obtain the approval;

4、 审核团队成员准备的提交资料并保证符合质量和法规要求；Review the submission document prepared by team members, and meet the quality and meet the regulatory requirements;

5、 协调并支持临床试验GCP检查和生产基地GMP检查和注册检查；Coordinate and support the GCP and GMP on-site inspection and registration inspection;

6、 对已上市产品变更和再注册项目进行评估，制定策略和计划并组织团队完成申请和批准；Assess the variation and license renewal of post market products, and develop the strategies and plan, and organize the team members to complete the submission and approval;

7、 研究并掌握最新注册相关政策法规、技术技南，评估其影响。Learn and master the updated regulatory policy and new regulations, guidelines, and assess their effects.

8、 与NMPA等相关药政管理部门、同行业加强联系，增强相互了解; Enhance the communication with NMPA, and connection with the industry and improve the understanding with each other;

9、 根据相关职位的岗位职责和能力要求，培养并提高下属业务能力，发展团队能力，以适应业务发展；Develop the team members’ capabilities and skills based on the related JD requirement, and cultivate the team competency to contribute the business goals;

10、 根据注册部各项目目标，制定科项目的年度预算并合理实施，指导并审核下属的出差、报销请假等申请，发现问题并及时修正；Set the reasonable annual budget for RA section 2 based on the RA objectives, and implement it in efficient way. Instruct and check the team members’ travel plan and reimbursement/vacation applications.

11、 紧密配合各相关部门，协助完成临床、医学相关资料、新BD项目的注册可行性评估。收集并分享竞争产品的注册相关情报。 Cooperate with the related department closely, and help them for the clinical/medical information preparation, and conduct the feasibility assessment for the new BD project. Collect and share the regulatory intelligence information for compete products.

完成总监交办的其他任务。Other tasks the director required.

任职要求：

• 8年以上注册相关经验，其中5年以上外资医药行业注册项目管理经验 more than 8 years RA experience, and more than 5 years RA project management experience in foreign pharmaceutical companies;

• 大学硕士或以上学历，医学、药学或相关专业毕业Master Degree or above, major in Medicine, pharmaceutical science, or related subjects.

• 领导力；较强的沟通及表达能力；制药行业注册法规、流程经验；组织协调能力；Leadership, good communication and expression skills, familiar with the drug registration regulations and procedures. Good organizing skills;

• 熟练的英语听、说、读、写能力Good Listening, speaking, reading, and writing in English

    第一三共集团是一家具有百余年历史的跨国制药企业，总部位于日本东京，全球约有1.5万名员工。在全球范围内专业从事各类医药产品的研究、开发、生产和经营的多元化制药集团。

    第一三共在中国已开展了三十多年的业务，我们提供的医药产品覆盖各治疗领域，抗感染治疗药-可乐必妥、高血压治疗药-傲坦和降血脂药-美百乐镇、止咳药-阿斯美、止痛药-乐松以及治疗前列腺肥大的优利福等药物，为广大的中国人民减除了病患。目前有员工近一千三百名，并在全国各级城市设有分支机构开展医药事业。第一三共（中国）投资有限公司作为第一三共在中国的地区总部,统一管理在华业务。第一三共制药（北京）有限公司和第一三共制药（上海）有限公司作为生产基地，生产的药品被广泛用于各个医疗领域。
    第一三共秉承作为与生命密切相关企业应有的高度伦理观和良好的社会意识开展各项业务，以此积极满足来自不断变化的多样化社会的要求，提升企业价值。我们严格按照GMP要求进行生产和质量控制，用专业的服务意识和奉献精神将最新的临床药品信息和治疗手段及时准确地传递给医务工作者，切实满足医疗需求，提供有用且值得信赖的高品质医药品和服务。

    Innovation、Integrity、Accountability是我们的源动力。
    第一三共始终坚持：激情创新。真情为您。　Passion for Innovation. Compassion for Patients.