长沙招聘

职位描述：
About RA Manager Healthcare
To provide the regulatory and drug safety support for Reckitt Benckiser healthcare products and ensure on-going compliance, leading to the growth of business in China, details as below:
? Provide the regulatory and product safety support for the product portfolio in China.
? Ensure on-going regulatory and product safety compliance of Reckitt Benckiser existing product portfolio
? Lead and co-ordinate the resolution of regulatory, medical and product safety issues affecting products in China.
? Provide regulatory affairs support and consultancy to internal and external customers in a business oriented way
? Work closely with external partners, contractors and licensees to ensure that regulatory, safety and medical affairs issues are properly managed and resolved.


Key Responsibilities
? Responsible for the regulatory activities for all healthcare products within China.
? Ensure the registration and regulatory compliance of Reckitt Benckiser’s marketed products with relevant national regulatory requirements to bring competitive advantage to our healthcare brands.
? Ensuring the compilation of national dossiers for submissions to authorities.
? Ensuring the preparation, maintenance and update of product registration/license and regulatory compliance files.
? Ensuring the amendment of registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration/variation applications and negotiating with governmental authorities to obtain rapid approvals.
? Developing national texts (e.g., PIL, SPC, packaging) including coordination of translations.
? Developing and maintaining a database of local regulatory requirements.
? Providing regulatory and product compliance expertise in the healthcare area of advertising, label claims and printed materials for existing and new products.
? Support the management of Pharmacovigilance activities for all healthcare products are carried out within China.
? Manage assigned specialist products.
? Keep abreast of the local and global regulatory environment and execute assigned regulatory activities.
? Work with Regional Regulatory Affairs Director to execute activities in China.
? Regular updates on latest regulatory affairs development in China and provide insights on compliance matters and healthcare related regulatory affairs.
? Interfacing with local government agencies and industry associations to assess the impact and implementation of required company compliance with all healthcare related regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products.
? Representing Company interests with local 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.

QUALIFICATIONS
Key Challenges
? In-line with global and local plans ensure successful delivery of all healthcare projects in the China.
? Work in partnership with global to formulate appropriate healthcare local strategy
? Work in partnership with the business to ensure the effective operation of local healthcare services.
? Ensure global and local technical and information standards are implemented and complied with at all times.
? Proactively manage local healthcare issues & ensure best practices are communicated and escalated effectively.
? Ensure training and development for end users on all healthcare regulatory related knowledge, skills and responsibilities.

Qualifications and Skills
? Graduate level in life science, preferably in pharmacy.
? Registered pharmacist is advantage
? 4-6 experience in regulatory affairs, preferably in MNC pharmaceutical or FMCG Company. 举报 分享

利洁时桂龙药业，成立于1989年，是中国中药行业知名企业，主打品牌：慢严舒柠和桂龙牌，2013年1月英国500强企业利洁时集团全资收购桂龙药业。目前与杜蕾丝，滴露，薇婷等品牌同为英资500强全资子公司。

公司拥有员工约1000人，总部位于福建省厦门市，在安徽省马鞍山市和山西省忻州市设有两个生产基地，总占地面积11万平方米，建筑面积近4万平方米，均为现代化的花园式GMP工厂。 桂龙药业在全国设立27个销售办事处，拥有500人的销售团队，销售人员有效管理近6万家零售终端门店，产品覆盖全国近三十万家零售药店，以及全国所有主流连锁药店。
桂龙，取自谐音“贵”“隆”，意为富贵华荣兴旺发达。且“桂”，有桂树四季翠绿，香飘万里而古朴典雅，是传统中药的化身；“龙”，象征着东方文化与蓄势勃发的力量。桂龙药业专注于中药呼吸系统和咽喉品类领域，创立了国内呼吸系统和咽喉领域两大知名品牌“慢严舒柠”牌，“桂龙”牌。以健康民众为使命，致力成为中国呼吸系统领域的领先中药制药企业，尤其在咽喉疾病的预防及治疗方面，始终保持领先，树立***，用心回报社会为目标。秉承祖国传统中医药理论，立足中药领域，创新发展中药组方及工艺，生产符合国际标准的中药产品，为普罗大众健康服务。
利洁时在中国
利洁时在中国的发展一直以生产和推广高品质的健康、卫生和家居护理用品、推动健康护理事业的发展为目标。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品质的家庭清洁产品。利洁时中国目前拥有近2，000名员工，总部设在北京，在各城市均设有办公室。在山东青岛、湖北荆州、山西、安徽设有工厂，利洁时中国旨在生产及推广高品质的健康、卫生和家居护理用品，并致力于发展健康护理产品。以中国的人们更健康, 生活更美好为愿景。致力于成为行业内领先企业，提供值得信赖的解决方案，让中国的人们更健康，生活更幸福。
利洁时健康护理、卫生护理及家居护理产品遍及全球180多个国家。在中国，利洁时的品牌家喻户晓：
健康护理：桂龙、慢严舒柠、杜蕾斯、爽健
家居护理：安悦嘉、渍无踪、巧手
卫生护理：滴露、亮碟、薇婷


【薪酬】
 公司向员工提供极富竞争力的薪酬待遇，并通过内部激励机制与调薪机制，使员工绩效表现同薪酬回报紧密联系，确保优秀员工获得更多的认可与激励。
【福利】
 社会保险：享受国家规定的养老保险、基本医疗保险、工伤保险、失业保险、女职工生育保险；
 公积金：享受国家规定的公积金；
 生活福利：提供每年健康体检、结婚礼物、生育礼物、防暑降温补助；
 各种假期：国定法定节假日、年休假、婚假、丧假、产假；
 桂龙爱心基金：在员工或家庭突遭变故时，给予慰问关怀及经济援助；
 快乐活动：定期员工集体旅游活动，中秋博饼、尾牙宴活动；
【培训发展】
 新员工入职培训：每位新员工入职都接受公司员工手册、规章制度、企业文化、职业心态的培训；
 岗位培训：针对不同岗位，公司会制定好计划，进入公司后一系列的岗位专业技能课程将帮助你提升专业技能，拓展知识的深度和广度；
 职业素质培训：通过各种内训、外训，提升员工的自我管理、人际沟通、团队合作、问题解决、责任心、主动性等通用职业素质全方位的培训，使您成为一名优秀的职业人。