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工作職責(zé):The Regulatory Affairs Manager assists with the regulatory maintenance of a portfolio 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 notifications, when required. The Regulatory Affairs Manager will assist the line Managers on specific projects, and in some instances will be responsible for their own projects. The Regulatory Affairs Manager ensures that each project operates within the set timeframes, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Pfizer Standard Operating Procedures. The Regulatory Affairs Manager may also be required to assist on special projects for the Regulatory Affairs Group. Ensure optimal regulatory compliance in China.I. ResponsibilitiesPrepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, where required.Critically analyze data packages for regulatory compliance and identify discrepancies in data presented and request additional data.Develop an overall perspective of registration projects.Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes.Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals.Maintain and update the Local Product Document (labeling) and Artwork in accordance with relevant regulations and PPG SOPsMaintain an up to date knowledge of the relevant legislation in China.Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.Provide regulatory advice to company personnel as required.Partner with the global regulatory and clinical development team in China PBG BUs for new products development strategy and inline products strategy.Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.Partner with PGS for supply strategy to avoid supply issue due to site changesProvide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practicesII. Ensuring Regulatory ComplianceEnsure 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 sitesEnsure 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任職資格:QUALIFICATIONS / SKILLSEducationTertiary qualifications in pharmacy or a science degree with a pharmacology major.ExperienceAt least 6 years experience in regulatory affairs working.TechnicalGood working knowledge of international and local regulatory guidelines and codesProficiency in Basic Microsoft Word, PowerPoint and ExcelAbility FunctionalOrganizing and planningCommunication and interpersonal skillTeam spiritGood sense in the areaProblem solving?? 職能類別：藥品生產(chǎn)/質(zhì)量管理