RA Manager 北京

月薪： 25-55万/年

该公司所有职位
  • 无工作经验
  • 招1人
  • 02-22 发布

职位描述

RESPONSIBILITIES:1.Regulatory Strategy: Develop and implement regulatory strategies that enable the delivery of a pipeline of product innovation to meet the Category Strategies for the relevant Personal Care category segment(s) Identify and recommend key strategic opportunities within own area of responsibility 2.Global / Core Regulatory Dossier: Work collaboratively with appropriate company personnel and contractors (when required) to define global, core registration dossiers Accountable for all regulatory and safety specifications to ensure that Reckitt Benckiser’s products conform with legislative, Health and Safety and environmental requirements Provide regulatory and product safety expertise in the area of advertising, label claims and other written materials for existing and new products Promote the use of standard test methodologies and reporting formats for regulatory & safety information 3.Management of Regulatory Issues: Monitor, collect and interpret regulatory issues and trends that will impact Reckitt Benckiser Personal Care products, policies and procedures, share this information with appropriate local and global functions and assist in the development of strategies and plans of action to address them 4.External Affairs: Interface with relevant government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products Interface and represent company interests with relevant government agencies, industry associations and/or other organizations for the purpose of negotiating legislation, regulations and/or guidelines that do not impose excessive or unfair burdens on our industry or products 5.Advice / Training: Advice Global Category Development, regional R&D Scientific Services, Regional Regulatory & Medical Affairs Groups and business personnel on regulatory requirements and regulatory impact during the early phases of the NPD process for projects intended for launch Provide advice and training on regulatory compliance, quality / GMP requirements to the local business Prepare training materials for internal training (e.g., for sales, marketing and customer service personnel) and conduct training sessions on relevant scientific, regulatory and safety issues 6.Audits / Continuous Improvement: Lead internal investigations into allegations of non-compliance and coordinating the activities necessary to expeditiously resolve local regulatory dispute; assisting in the organization of internal audits and monitor audits performed by 3 parties Work jointly with R&D Director Global RSE H&PC to define self improvement program Assist Heads of Regional Regulatory & Medical Affairs Groups to conduct internal audits to ensure regulatory and safety compliance Maintain and report on agreed key performance indicators7.Safety and Environmental Affairs Ensure safety evaluation and health risk assessment are carried out for products within assigned Personal Care Category segment(s) in accordance with company policy and guidelines to support product registrations Coordinate and manage interactions with medical and legal profession concerning safety, environmental or medical product liability issues of all marketed products, while minimizing the financial impact and maintaining the integrity of our corporate image Assist in the preparation of responses to address significant safety and / or regulatory issues relating our products Provide technical support to respond to consumer and legal inquiries concerning technical, safety, and environmental and regulatory issues for our products Support internal investigations into allegations of non-compliance and coordinate the activities necessary to expeditiously resolve regulatory disputes. Manage statutory reporting requirements, as required 8.People Development Recruit, retain, motivate and develop people within a results-oriented culture, where personal responsibility/ initiative, teamwork, and mutual respect are key 9.DSO QUALIFICATION AND REQUIRED SKILLS1.University Science degree in a relevant Scientific discipline, with pharmacy or medical qualifications a plus Experienced in the OTC market and within an FMCG environment, or within a pharmaceutical environment, with experience managing Medical, Regulatory and / or Safety functions 2.Broad knowledge of regulatory and Personal Care systems 3.Experience in handling corporate crisis management and issues resolution 4.Demonstrated ability to handle competing priorities effectively 5.Sound performer in interacting with, and influencing regulatory authorities and political lobbies 6.Proven track record in active collaboration with R&D and non-R&D functions as well as third parties 7.Experience with recruitment, management and development of people 8.Proven experience in leading multi-functional and multi-cultural project teams, virtually 9.Proven track record as a top performer in defining and implementing projects, and problem solving 10.Clear and logical thinker with the ability to recognize patterns and develop innovative solutions 11.Ability to apply argumentation in order to influence at all levels externally and internally 12.Pro-active self-direction with a high level of initiative and persistence and a very much hands on approach to results delivery 13.The ability to effectively manage projects and relationships with local partners, contractors, and consultants to achieve RB’s objectives. 职能类别： 药品注册 生物工程/生物制药 关键字： 医药注册

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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