RA Director (职位编号：93458926)社

面议

市辖区硕士及以上9年及以上

发布时间：2023-09-06

职位描述

工作职责

Responsible for planning and preparing the regulatory CMC strategy for assigned projects (both marketed and new products)Independently responsible for regulatory activities and CMC strategy implementation for assigned projects (both marketed and new products)Early identify potential CMC risks and propose the solutions for assigned projects and be able to influence the HAs' decisions.Serve as a primary contact person with HAs for assigned products/projects CMC technical reviewing.Build a good working relationship with HAs and academic associationResponsible for internal communication for assigned products/projects and represents China RA CMC position and influence by given insight and technical input to drive achievable results, including both local quality, supply chain and global functionsManage people to take the responsibility for the assigned projects and give guidance to subordinates if applicableEnsure the compliance of Company internal Policy/ system/ database/ responsible projects and local regulation compliant behavior/sub-group. Should be able to foresee potential risks of compliance, especially from CMC perspective.任职要求

Education and experience:Advanced technical degree (Ph.D., D.V.M. or Pharm.D. in life sciences with 8 years of regulatory experience or . MS with 10 years of regulatory experience or . BS with 12 years of regulatory experienceKnowledge:In-depth knowledge of regional HA regulations to support filings. Some familiarity with global regulations.Knowledge and experience in drug development (manufacture, quality control, analytical, CTD, ICH guideline, GMP, QBD,etc.)A thorough knowledge of company policies and procedures in drug development and product maintenance requirementsThe position requires scientific and technical expertise, including the ability to develop robust CMC regulatory plans covering all phases of drug developmentSkill :Excellent communication skills, verbal and written, are requiredDemonstrated ability to influence in a team environmentThe ability to work within a global team framework and a multi-cultural environment is requiredStrong analytical skills are requiredDemonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skillsMust have the ability to organize and direct diverse activities in a changing environment often under time pressure.Demonstrated problem solving as applied to local regulatory issues

其他要求

招聘人数：1人
职能类别：工程项目经理

公司介绍

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**、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**网站****************