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无工作经验 -
招1人 -
11-09 发布
职位描述
职位描述： Major Accountabilities:Drug registration strategy？Plans, reviews and recommends the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for Sandoz BD &L and pipeline products based on regulatory expertise with country regulations & local processes.？Manages and ensures that the country Regulatory Plans are in alignment with Launch strategies, BD&L and the country’s business plan.？Plan and align with RCC/LCM/DRC/MRC/SDC to obtain dossiers for local submissions.Dossier Preparation & Gain Regulatory Approval？Initiate dossier preparation, request available regulatory documents from HQ and within Sandoz China (Scientific Affair, Clinical Affair, and Tech Op)？Coordinate the patent search and confirm the administration and new drug protection in Chi-na？Review registration dossiers, to ensure registration documentation to confirm the requires of CFDA？Initiate and confirm translation of dossiers for all documents received into Mandarin (or into English) through project team review？Ensure registration documentation, samples submission and process to related government department？Supports product launches by cross checking documents of products for launch？Manage the final product submissions and negotiate and communicate effectively with HA to obtain timely product approvals of products for Sandoz’ out-licensing business and product launches？Prepares and reviews technical dossier of BD&L and launch products within the planned affiliate timeline？In-charge with the timely approval of Certificate of Product Registration of the products for launch and related to BD&L, company licenses, pre- and post-approval variations, permits and other applicationsProjects/Others？To be a good coordinator for 3rd researching company.？Ensure all preliminary work requirement to successfully launch a product that are out-licensed are completed？Responsible for preparation of regulatory submission strategies to expedite MA release for products for BD&L and launch.？Educate the affiliate the value that the regulatory function can significantly contribute to the business.Compliance / regulatory requirements？ To support timely launch and secure continued business by ensuring timely regulatory maintenance.？Implement regulatory quality plan and QA systems and generate SOPs？Manage to maintain all local marketed products in compliance with local and corporate regulatory requirements.？Provide appropriate solutions for compliance issues？Good Regulatory Practice？Maintain a current awareness of the regulatory requirements for the marketing of medicinal products in China and general legislation and guidelines relating to medicinal products in the Country.？Liase with RCC/LCM/SDC/DMRC/NTO/QA/SC to ensure timely submission of variation packages.Background:Education:University degree in the life sciences ,Scientific academic degree, preferably in pharmacy、medicine、bio-sciencesLanguages:Good command of local and English languageExperience:At least 5 years’ experience to board multi-functional experience in pharmaceutical development process and science, specifically in regulatory, clinical or chemistry.Past 3 years people management experience will be considered.Competency:？Negotiating？Priority Setting？Drive for Results？Process Management？Business Acumen？Problem Solving？Decision quality？Functional Technical Skills 职能类别： 药品注册
联系方式
建国门外大街1号国贸大厦2座
公司信息
山德士是瑞士诺华集团的子公司，诺华集团是世界第三大制药公司、世界500强企业，是全球唯一在专利药、非专利药、疫苗和非处方药业务上都拥有领导地位的制药公司。诺华集团成立于1996年，由瑞士两家具有百年历史的世界著名制药公司汽巴-嘉基与山德士合并而成。山德士主要从事非专利药品的研发、生产和销售，业务涵盖原料药、制剂和生物制品，拥有950多个化合物和5000多种制剂，是全球第二大非专利药公司。山德士（中国）2007年1月正式开展中国业务，于当年12月20日向德国格兰泰公司收购了位于中山市火炬区健康基地的中山格兰泰制药，并在中山成立了山德士(中国)制药有限公司，注册资金2200万美元，投资总额达3500万美元.
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