注册副经理

招聘人数：1 人 性别要求：不限性别 工作职责:Primary Responsibilities Collaborate an d Communicate with China GEP an d GIP President on the ways to help the Ｃountry meet annual objectives of different BUs an d ensure regulatory supports to the marketing an d sales effort through:1. New Drug an d 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 an d renewals to marketed products an d clinical trial applications, where required1.2 Critically analysis data packages for regulatory compliance an d identify discrepancies in data presented an d request additional data1.3 Develop an overall perspective plan of registration projects1.4 Prepare responses to deficiency letters an d ensure that these an d other data requirements are submitted to regulatory agencies within the stipulated Ｏr agreed timeframes1.5 Maintain an d Ｕpdate the Local Product Document （labeling） in accordance with relevant regulations an d PPG SOPs1.6 Maintain an up to date knowledge of the relevant legislation in China 1.7 Maintain adequate product knowledge to ensure prompt an d professional responses to queries relating to company products1.8 Provide regulatory advice to company personnel as required1.9 Partner with the global regulatory an d clinical development team in GIP/GEP BUs for new products development strategy an d inline products strategy.1.10 Partner with PGS an d Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia （CHP） an d 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, an d practices2 Build-up Relationships with Both Relevant Government Agencies an d Corporate Supporting Teams, Ensure Compliance with the Regulations an d Expedite Approvals 2.1 Well understand regulations an d build up a platform to communicate with officials2.2 Provide necessary an d 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 an d building strong company image 2.4 Actively collect information an d 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 an d other China regulations to PGS QO an d GCMC to facilitate the implement of CHP an d other regulations in PGS sites3.2 Ensure local process in place for the timely submission of all the quality an d safety relevant variations including labeling safety Ｕpdate an d 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 an d other internal meetings as required5.2 Provide a resource Ｏr supports for other sections of the company for specified therapeutic areas任职资格:Technical Skill Requirements1. Ability Functional1.1 Organizing an d planning 1.2 Communication an d 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 an d 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 years 2.3 Experience in more than one therapeutic areas2.4 Good working knowledge of international an d local regulatory guidelines an d codes.2.5 Fluent in English both in written an d speaking, Proficiency in basic computer skills including Basic Microsoft Word, PowerPoint an d Excel an d familiarity with use of databases.