Regulatory Affairs manager招聘_爱尔康（中国）眼科产品有限公司 Alcon (China) Ophthalmic Product Co., Ltd.最新招聘信息-猎才医药网

职位描述

职责描述：? Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for all new products and life cycle management of marketed products in China, aligned with Global regulatory and China business strategies and plans for Rx and OTC business.? Provides guidance in aligning regulatory affairs in China and globally to ensure synergy and integration globally, and ensuring strategic input into product-related activities (development and lifecycle).? Responsible for driving performance as measured by expeditious development of plans, regulatory submissions and approvals in China for Rx and OTC business. ? Monitor operational progression of pre-marketing authorization activities at country level through contact with country regulatory agencies or committees, as required.? Strategic communication with the country regulatory agencies or committees to expedite new marketing authorization approvals and other operational regulatory interventions? Provide leadership to ensure that sound regulatory practices are fully integrated in all pre-clinical, clinical and technical submissions and evaluate all documents submitted to regulatory agencies to ensure they are complete, well organized, scientifically accurate, of high quality, in regulatory compliance, and presented in a manner that facilitates agency review.? Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks; ensure that development and manufacturing activities meet all relevant requirements and guidelines.? Provide regulatory intelligence related to the eye care industry. Monitor developments in local legislation and guidelines applying to pharmaceutical and medical device products in the region and implement for products approved in China through the centralized, mutual recognition and decentralized procedures? Contribute to the global strategies for the expeditious and effective development, registration and lifecycle management of the Rx and OTC products.? Work with Rx and OTC commercial colleagues to develop global promotional strategies and provide regulatory review for promotional materials ? Provide regulatory evaluation for in-licensing opportunities.任职要求：Education / General University degree or equivalent in biomedical field and higher degree with minimum 7 year experience in Rx and/or OTC Regulatory Affairs required, not less than 3 years of which shall have been in a managerial role, interacting to affect direction and decision-making within development programs and in regulatory agencies.Expertise/Experience/Skills? In depth knowledge of the regulations affecting the drug industry in China; including both pre-market and post-approval regulations. A working knowledge of regulatory review and approval processes in other global markets ? Knowledge of the policies and regulatory climate within global health authorities.? A history of positive working relationships with senior officials within major regulatory agencies and a track record of success in gaining China drug approvals.? Significant experience presenting to regulatory authorities.? Ability to interact effectively across boundaries with other global functions.? Action oriented with proven ability to move projects through to approval and commercial success.? Strategic and technical expertise required to align with the Alcon’s global regulatory strategy and develop and implement the Area's regulatory strategy. ? Well developed project management skills with the demonstrated ability to provide direction to others in cross-divisional project team environments and in matrix reporting relationships. ? High energy, hands-on individual with a collaborative personal style and the ability to work well in a team environment.? Ability to develop and implement strategic growth plans; ability to multi-task and to interact and negotiate with diverse groups on an international scope.? Transparent communicator.. 职能类别：医疗器械注册药品注册

公司信息

爱尔康（中国）作为全球眼科领域的领导者，爱尔康的使命是通过创新型产品，提高视觉质量，提高生活品质。这个使命意味着爱尔康22000多名员工为“保护、恢复和提高视力”的目标进行着不懈的努力与奋斗,使散光治疗，青光眼治疗，近视眼激光视力恢复矫正等等技术得到更好，更全面的普及，努力改善更多人的视力健康。诺华和爱尔康合并后，爱尔康、视康和诺华眼科的优势融合到同一眼科保健业务，爱尔康已成为诺华集团第二大业务部门。公司合并带来的整合资源和业务覆盖的优势，爱尔康现在180个国家销售全线的眼科保健产品，包括手术产品、药品和视力保健产品，并在75个国家拥有分公司。从一个孩子为矫正近视眼配的第一副隐形眼镜，到她的祖父母为治疗白内障而做的人工晶体植入，爱尔康的创新产品帮助各个年龄段的患者更清晰地看到世界。爱尔康的产品与高科技可用于解决诸多领域里日益增长的临床问题，例如白内障、青光眼、视网膜疾病、屈光不正、眼部过敏、眼部干涩、感染和发炎以及许多其他眼部护理需求。在全球范围内，爱尔康有近2000名员工致力于研发工作，以满足世界上最迫切的眼部护理需求。同时，我们的业务也延伸到专业教育领域并在整个行业内处于领先水平。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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