Regulatory Affairs Manager 北京

月薪：

该公司所有职位
  • 3-4年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 员工旅游
  • 交通补贴
  • 年终奖金
  • 通讯补贴
  • 餐饮补贴
  • 定期体检

职位描述

职位描述： REPORTS TOAssociate Regulatory Affairs DirectorREQUIRED QUALIFICATIONS AND EXPERIENCE？ Life sciences degree (preferable pharmacy degree).？ Fluent English (both oral & written).？ Minimum of 3-5 years with regulatory affairs activities in multi-national pharmaceuticalcompany, experience with specialty care products preferred.？ Profound knowledge of national health authority and industry regulations, policies andguidelines.？ Understanding of the drug development process.？ Negotiation skills, project management skills.？ Persuasiveness, influencing and coordination skills.？ Effectively working in team within a country and globally.RESPONSIBILITIES AND TASKSDrug regulatory affairs:？ Expedites the registration of new products/biologics/line extension/claims andcontinued approval of marketed products.？ Prepares and manages regulatory submissions, progress reports, supplements,amendments, or periodical experience reports to the local Health Authority throughoutdrug development, registration and life cycle management.？ Coordinates and supports interactions between the company and healthauthority/regulatory agency representatives and CRO partners to facilitate clinical trialapplication and NDA programs through development to approval and during life cyclemanagement？ Answers regulatory questions from health authorities in close collaboration with GlobalDRA and CRO partners.？ Develop and maintain relationship/partnerships with local Health Authority andProfessional Association/Organization.？ Maintain working knowledge of current governmental and worldwide requirements anddetailed knowledge of local regulations for initial registration, re-registration and post-approval changes.？ Collects relevant public available regulatory information (regulatory intelligence) andkeeps relevant persons appropriately informed.？ Participate in some of the following: product plan development and implementation,regulatory strategy, risk management.？ Works alongside Business Development, locally, regionally and globally, to supportbusiness initiatives in sub region.？ Ensures compliance of company products and activities with local guidelines andcodes (e.g. Labelling, advertising/promotion), champions best practices and promotesoperational excellence. 职能类别： 药品注册

联系方式

中国北京市建国门外大街甲14号北京广播大厦16层1602-2室；

公司信息

Actelion Pharmaceuticals Ltd (“Actelion”) is a biopharmaceutical company and public listed in Switzerland. Actelion is focusing on the discovery, development and commercialization of innovative treatments to serve high unmet medical. Actelion has offices in more than 25 countries.

北京相关职位

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企业入驻日期： 2017-11-09

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