辉瑞

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全球最大的以研发为基础的生物制药公司

高级注册经理

工作要求

  • 工作地区:北京
  • 工作经验:8年以上
  • 职位类型:全职
  • 工资待遇:¥ 面议
  • 学历要求:本科以上
  • 工作地址:朝阳门北大街3-7号五矿广场

岗位职责/工作内容/岗位要求

工作职责:The position is responsible for the regulatory maintenance of portfolio products and regulatory approval of products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial approvals. The SRAM is also responsible for the specific registration projects to ensure that each project operates within the set timeframes and conducts in accordance with local regulatory agency requirements and relevant Pfizer SOPs.Supervising and coaching subordinates if necessary; Build up strong relationship with relevant government agency and keep closely contact with corporate supporting teamThe role will take a special focus on multiple therapeutic area designated to him to her. This will require the SRAM to maintain a global overview of the therapeutic areas, in respect of the Company’s products, competitor products and treatment standards. Thus providing this expertise to the clinical develop and medical group as well as to other Company personnel where required.Ensure optimal regulatory compliance in China.Primary ResponsibilitiesCollaborate and Communicate with China PBG President on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:1. New Drug and Inline Products Registration Planning &; Implementing for the therapeutic area of AI products.1.1 Set up new product registration plan, prepare the regulatory submissions for registration of new products, variations and renewals to marketed products and clinical trial applications, where required1.2 Critically analysis data packages for regulatory compliance and identify discrepancies in data presented and request additional data1.3 Develop an overall perspective plan of registration projects1.4 Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes1.5 Maintain and update the Local Product Document (labeling) in accordance with relevant regulations and PPG SOPs1.6 Maintain an up to date knowledge of the relevant legislation in China1.7 Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products1.8 Provide regulatory advice to company personnel as required1.9 Partner with the global regulatory and clinical development team in PBG BUs for new products development strategy and inline products strategy.1.10 Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.1.11 Partner with PGS for supply strategy to avoid supply issue due to site changes1.12 Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices2 Build-up Relationships with Both Relevant Government Agencies and Corporate Supporting Teams, Ensure Compliance with the Regulations and Expedite Approvals2.1 Well understand regulations and build up a platform to communicate with officials2.2 Provide necessary and timely supports to policy team for all the policy advocacy activities2.3 Efficiently use company resource to enhance the working relationship with relevant government agencies and building strong company image2.4 Actively collect information and monitor the change of regulatory environment;2.5 Strengthen the liaison with corporate support teams via various tools or communication channels during daily operation3 Ensuring Regulatory Compliance3.1 Ensure timely communicate the requirement of CHP and other China regulations to PGS QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites3.2 Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and specification/manufacture process change4 Special Projects4.1 Be required to participate on special projects for the Regulatory Affairs Group5 Marketing Support5.1 Attend Regulatory Affairs Department, new product development , Medical and other internal meetings as required5.2 Provide a resource or supports for other sections of the company for specified therapeutic areas6 People Management &; Team Work Spirit6.1 Demonstrate and influence the team on leadership behavior and core value in daily work, in terms of coaching and developing people; information/ best expertise sharing; positive and constructive way of communication (frank, honest, friendly etc)6.2 Ensure effective communications between Regulatory Affairs Department and other functional teams within company.7 Personal Development7.1 Complete the Pfizer PRE Safety Reporting Process: Overview training module in the set timeframe7.2 Attend and actively participate in personal development courses as required7.3 Attend training in specific therapeutic areas as required.7.4 Lead Regulatory Affairs, Clinical development and Medical Department projects and workshops任职资格:Technical Skill Requirements1. Ability Functional1.1 Organizing and planning1.2 Communication and interpersonal skill1.3 Team spirit1.4 Good sense in the area1.5 Problem solvingComputer skill2. Cultural Competencies (Leader Behaviors)2.1 Sustain Focus on Performance2.2 Create an Inclusive Environment2.3 Encourage Open Discussion and Debate2.4 Manage Change2.5 Develop PeopleAlign Across PfizerQualifications (i.e., preferred education, experience, attributes)1. Educational /TrainingBachelor degree or above in Pharmaceuticals, Pharmaceutical chemistry, Medical, Biologic or related sciences with a pharmaceutical major2.Working Experiences2.1 At least 8 years experience in Chinese regulatory affairs working at a high level of competency2.2 Independently lead a team with multiple therapeutic areas for at least 2 years2.3 Experience in more than one therapeutic areas2.4 Good working knowledge of international and local regulatory guidelines and codes.2.5 Fluent in English both in written and speaking, Proficiency in basic computer skills including Basic Microsoft Word, PowerPoint and Excel and familiarity with use of databases.

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最近更新:
2019-11-12
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