深圳招聘

-Proactively work cross-functionally with key stakeholders within R&D organization and beyond (e.g., Medical Affairs, Pharmacovigilance, Health Policy, Government Affairs) to cooperate and collaborate on regulatory policy and health policy topics and issues.
-Provide executive-level staff support to China RA Head in RDPAC Committees and work groups (for example), developing Bayer positions in cooperation with Health Policy and Public & Governmental Affairs on regulatory reform topics.
-Support RA strategic initiatives and other cross-functional projects (e.g., RA 2023 Roadmap, Operational Excellence, data science and innovation).
-Proactively monitor and screen draft and final legislation, regulations, guidelines and other information on drug development and regulatory matters issued by the Health Authorities - with the main focus on the China health authority (e.g., NMPA), in order to identify those that may have a relevant impact.
-Lead the Health Authority commenting process within China and Asia Pacific region by coordinating and guiding the review assessment and generation of aligned Bayer positions, including seeking and gaining consensus among internal stakeholders where needed.
-Gather and collect competitor regulatory intelligence and Health Authority benchmarking data on performance measures, and communicate across the organization. Extend support of regulatory intelligence needs for Medical Affairs, Pharmacovigilance, Clinical Development, Operations.
-Maintain an effective Regulatory Intelligence database, providing Regulatory Intelligence expertise regarding regulatory requirements and competitor environment for development projects and for marketed products, in order to allow Regulatory Affairs functions to anticipate and effectively implement new regulatory compliance obligations.
-Help drive operational improvements including development and use of Technology-enabled analysis and reporting tools to deliver actionable regulatory insights, including creation of a regulatory intelligence dashboard, trend analysis, and other data visualization tools.

职位要求：
-At least a BSc degree or equivalent is required (MSc preferred) with at minimum of 5+ years of experience in regulatory affairs.
-The individual must have a very good overview of the current regulatory environment in China, in particular how the regulations apply to theregulatory activities of the company.
-Working experience in a regulatory affairs environment and knowledge of current and on-going regulatory reforms in China, including changes within NMPA divisions, personnel and procedural concepts is highly desired. The position requires diplomatic, scientific and technical expertise.
-An excellent knowledge of drug regulations and guidance documents on drug development, new drug applications, variations and line extensions in all main countries is required. Ability to influence, to build relationships with regulatory bodies, associations and stakeholders, and to successfully negotiate is required.
-Affinities for using new and novel technologies for enhanced efficiency and achieve operational objectives.
-Good communication skills, verbal and written, are imperative.
-Good English skills, oral and written.

拜耳是一家全球化创新型企业，在生命科学领域的健康与营养方面具有核心竞争力。拜耳致力于以创新的产品帮助解决当今人类社会所面临的一些重大挑战。随着人类预期寿命不断延长，人口不断增长，拜耳通过专注于预防、缓解和治疗疾病的研发活动来改善人们的生活质量。与此同时，拜耳通过突破性创新引领农业未来，帮助农户、消费者得到健康、安全、可负担的食物，并且生产过程对社区、对环境友好。“拜耳：科技创造美好生活”是我们的使命，我们的目标是改善人们的生活质量。

拜耳于1863年创立，迄今已有150多年的历史，公司总部位于德国勒沃库森，全球拥有超过11万名员工。2018年财富世界500强排行榜中拜耳排名193位。早在1882年拜耳公司首次进入中国市场，至今已经超过130年。随着中国成为世界上增长最快的市场之一，拜耳也逐步加大了在这里的投入。拜耳中国总部位于上海，截至2018年12月底，拥有超过9,000名员工。2018年拜耳中国的销售额达到31.27亿欧元，折合人民币超过235亿元。

拜耳在中国有三大事业部：处方药、健康消费品和作物科学，并运营着多家工厂。早在1936年拜耳就开始在上海生产阿司匹林，目前本地生产在中国的销售额中所占比重越来越大。伴随着正在进行的一些重大投资项目，拜耳致力于成为在中国发展的主要引擎。

多年以来，拜耳作为人们心目中的理想雇主屡获殊荣，2018年我们荣膺中国杰出雇主、中国典范雇主、非凡雇主101-年度多元雇主、中国大学生喜爱雇主、最受***欢迎雇主等多个奖项。同时，拜耳也是提供均等机会的雇主。我们尊重并公平对待他人，不论其宗教、国籍、民族、文化、性别或性取向，我们重视并弘扬多元文化。“敢想|勇为”（Passion to innovate | Power to change）是拜耳的雇主品牌宣言，它概括了拜耳作为雇主的全部特点：其工作文化与公司对目前和未来员工的期望以及对他们的回报。

如需了解更多信息，欢迎访问拜耳官方网站www.bayer.com.cn