辉瑞

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全球最大的以研发为基础的生物制药公司

注册副经理

工作要求

  • 工作地区:北京-东城区
  • 工作经验:5-7年经验
  • 职位类型:全职
  • 工资待遇:¥ 10万以上/月
  • 学历要求:本科以上
  • 工作地址:朝阳门北大街五矿广场

岗位职责/工作内容/岗位要求

工作职责:
Primary Responsibilities
Collaborate and Communicate with China GEP and GIP 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 required
1.2 Critically analysis data packages for regulatory compliance and identify discrepancies in data presented and request additional data
1.3 Develop an overall perspective plan of registration projects
1.4 Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes
1.5 Maintain and update the Local Product Document (labeling) in accordance with relevant regulations and PPG SOPs
1.6 Maintain an up to date knowledge of the relevant legislation in China
1.7 Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products
1.8 Provide regulatory advice to company personnel as required
1.9 Partner with the global regulatory and clinical development team in GIP/GEP 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 changes
1.12 Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices
2 Build-up Relationships with Both Relevant Government Agencies and Corporate Supporting Teams, Ensure Compliance with the Regulations and Expedite Approvals
2.1 Well understand regulations and build up a platform to communicate with officials
2.2 Provide necessary and timely supports to policy team for all the policy advocacy activities
2.3 Efficiently use company resource to enhance the working relationship with relevant government agencies and building strong company image
2.4 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 operation
3 Ensuring Regulatory Compliance
3.1 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 sites
3.2 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 change
4 Special Projects
4.1 Be required to participate on special projects for the Regulatory Affairs Group
5 Marketing Support
5.1 Attend Regulatory Affairs Department, new product development , Medical and other internal meetings as required
5.2 Provide a resource or supports for other sections of the company for specified therapeutic areas
任职资格:
Technical Skill Requirements
1. Ability Functional
1.1 Organizing and planning
1.2 Communication and interpersonal skill
1.3 Team spirit
1.4 Good sense in the area
1.5 Problem solving
Computer skill
2. Cultural Competencies (Leader Behaviors)
2.1 Sustain Focus on Performance
2.2 Create an Inclusive Environment
2.3 Encourage Open Discussion and Debate
2.4 Manage Change
2.5 Develop People
Align Across Pfizer
Qualifications (i.e., preferred education, experience, attributes)
1. Educational /Training
Bachelor degree or above in Pharmaceuticals, Pharmaceutical chemistry, Medical, Biologic or related sciences with a pharmaceutical major
2.Working Experiences
2.1 At least 8 years experience in Chinese regulatory affairs working at a high level of competency
2.2 Independently lead a team with multiple therapeutic areas for at least 2 years
2.3 Experience in more than one therapeutic areas
2.4 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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