• 无工作经验
  • 招1人
  • 03-08 发布

职位描述

Position Title: Regulatory Affair Manager 职位:法规事务部经理 Roles and Responsibilities 工作职责 Division/Department: regulatory affairs 部门:法规部 Report to: Regional Regulatory Affairs Director, North Asia 向北亚区法规事务部总监汇报 ·Assist in regulatory processes to ensure timely filing, approval and renewal of new product new dosage forms, new strengths, new labeling registrations in accordance with business objectives. 依照公司计划和产品注册程序规定,按时申请和准备产品注册相关文档。 ·To assist in championing procedures to expedite commercialization of new products. 协助支持新产品的市场准入工作。 ·Builds relationships and negotiates with local regulatory agencies on all matters relating to healthcare product development, compliance and safety in local market 与当地政府部门建立良好的联系和沟通,有关市场的健康相关产品发展、相关法规及安全进行沟通。 ·Keeps abreast of regulatory changes and communicates aggressively to appropriate management team and to local and HQ regulatory, medical and marketing groups. 及时了解和更新政策法规,并及时与公司相关部门进行沟通。 ·Works with Quality and Brand Managers to ensure the all promotional materials are in compliance with local registration requirements 与质量部门及品牌经理合作,确保所有产品符合当地注册法规要求。 ·Follows up relentlessly with HQ regulatory affairs people to solicit input and support to be in-line with Worldwide registration efforts. 与总部法规同事密切联系,获得其最新信息及支持文件,以保持与全球注册计划同步。 ·Establishes strong working relationships with agencies, customers and business colleagues within RB to ensure all efforts are focused on successful commercialization of healthcare products. 与利洁时的代理、顾客及同事建立密切的合作关系,为公司的健康相关产品的成功销售共同努力。 ·Pays strict attention to details and accuracy whilst maintaining sense of urgency. 工作细心、准确、有效率。 ·DSO Application Requirement: 招聘要求: Education/Major:University Science degree in a relevant Scientific discipline, with pharmacy or medical qualifications a plus. 教育程度/专业:药学或医学相关专业Experienced in the OTC market and within an MNC environment, or within a pharmaceutical environment, with experience managing Medical, Regulatory and / or Safety functions跨国企业OTC产品相关管理经验,熟悉医学,法规或药品安全工作。Eng. (Read/Written/Oral): Fluent英文程度(读/写/说):流利PC Skills: Good电脑技能:熟练Experiences Desired经验要求:·Preferably Pharmacist with at least 8 years experiences in healthcare products management function or Science graduate with regulatory experience in healthcare product.拥有8年以上药品注册经验更为适宜。·Demonstrated ability to negotiate with people of various internal and external functions.拥有良好的部门内外沟通能力。·Experience in project management拥有项目管理经验·Demonstrated ability in time management拥有良好的时间管理能力·Assist as a team in planning and problem solving配合团队策划、解决问题·Demonstrated ability to work with a range of technically and culturally diverse people, influencing them to get things done, and delivering value-added business results that meet high quality requirement within tight deadlines.拥有与不同技术才能、文化背景的员工沟通能力,通过自身影响力为公司商业活动增值,能在有限的时间内实现高水平的目标。 Knowledge Desired知识要求:·Knowledge of local/regional regulatory processes and changes that are implemented or being considered.了解当地的注册程序及相关法规执行及可能变更的情况。·Knowledge of the local pharmaceutical, food, health food industry了解当地药物,食品和保健品产业·Knowledge of organization structure and policies of Health Authorities; Government Supplies Department; and local hospitals了解卫生部门、政府供应部门与当地医院组织结构及其政策。·Understanding of RB sourcing and regulatory procedures了解利洁时产品来源渠道及其相关法规程序。·Knowledge in regulatory compliance.了解法规政策。·Reasonable command in oral and written English communication skills拥有英语写作及口语沟通能力 Developmental Value:更高要求:·Awareness of the importance of cross-functional networks to achieve business results重视跨部门团队协作以达到公司商业活动目标·Greater contact with government regulatory authorities与政府法律部门有密切的接触·Assists in project leadership拥有辅助领导项目的能力 职能类别: 药品注册

联系方式

北京市朝阳区东大桥路9号侨福芳草地大厦D座6层

公司信息

利洁时是全球500强企业,是全球最大的家用清洁及个人护理消费品公司之一,总部位于英国伦敦。在60个国家运作高品质的家用清洁用品、个人护理用品和药品,产品行销180个国家和地区。我们的历史可以追溯到18世纪:在英国生产面粉的Reckitt和在德国生产工业化学原料的Benckiser。1888年开始,我们已经开始在伦敦股票交易所上市,通过合资,以及有选择性的并购,我们已经成为富时指数前25位的全球性公司。利洁时在中国的发展一直以生产和推广高品质的家庭清洁和个人卫生护理用品、推动中国健康护理事业的发展目标。作为蜚声国际的跨国企业,利洁时在中国市场生产和销售高质量的知名品牌家庭清洁产品。开发极具潜力的市场,始终是利洁时公司投资的核心战略之一。1995年利洁时来到中国,在广州成立了第一家合资企业-利高曼(广州)有限公司,1996年与湖北活力28集团合资组建了湖北活力美洁时洗涤用品有限公司,从此扎根荆州,开始了利洁时投资中国市场的历程。随着中国国际地位的提升,在加大投资及完成中国区域资源整合的同时,利洁时更坚定了在中国投资的信心。2006年,在中国成立了利洁时家化(中国)有限公司(利洁时全球全资子公司)。为了使中国区的工厂真正成为国际生产基地,几年来利洁时在中国的投资势头不减,在组织结构调整和人员配备方面更是格外重视。2010年随着利洁时全球收购了SSL集团,利洁时在中国增加了新的产品品牌,工厂以及团队。目前利洁时中国的品牌有:Dettol (滴露)Veet (薇婷)Finish (亮碟)Airwick (安悦嘉)Dosia (巧手)Durex (杜蕾斯)Scholl (爽健)Vanish(渍无踪)我们以我们自己在这个高度竞争的全球市场中创造的成绩而骄傲,并深刻意识到我们的成功是直接和我们善于接受挑战,充满热情和才华的员工联系在一起的。想要了解我们更多的历史和信息,请参阅公司网站 www.rb.com

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