上海相关职位： 研究助理 体外诊断芯片制造总监 项目经理 (职位编号：20171003) 大区销售经理 (职位编号：002) 中药饮片业务主管（OTC方向） QC 质量检验员 产品工艺主管/工程师 品质注册助理（实习） QC生化/微生物检验员 商务专员
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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无工作经验 -
本科 -
招1人 -
11-09 发布
- 五险一金
- 补充医疗保险
- 绩效奖金
职位描述
职位描述： Job Responsibilities: As regulatory the candidate will be a key regulatory expert for the portfolio of Process Solution, Food&Beverage and A&F, Merck Life Science, consisting of API, excipients, food additive, beverage, single use, filter, consumable and process materials for the biopharmaceutical industry. The candidate should have an understanding of regulations relevant to API, excipients, sterile drug manufacturing, and biopharmaceutical processing (upstream, downstream). In addition, the candidate must be well-versed in regulatory trends for API, excipients, single use, aligned with the strategy of Merck Life Science to build regulatory expertise relevant to Biopharmaceutical cGMPs.l Take active role to build regulatory intelligence for Process Solution, Food&Beverage and A&F.l Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Process Solutions, Food&Beverage and A&F interests.l Safeguard Process Solution, Food&Beverage and A&F strategic interests and objectives in arising guidance, standards and regulation.l Monitor and report on changes of relevant regulatory and compliance environment with impact with the business. Analyze available regulatory and compliance information.l Increases the influence of Merck in important regulatory bodies and industry associations.l Actively participates and represents Merck Life Science in relevant industry associations.l Effective coordination of strategic activities of subject matter experts in local regulatory bodies and industry associations.l Secure flow of information from/to authorities, industry associations and commercial organization.l Builds and keeps personal relationships to local and national authorities.l Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines, regulations and standards.l Training for and support of internal stakeholders, external customers and relevant regulatory bodies.l Provide relevant training to educate local Process Solution marketing/sales colleagues about new regulatory trends and developments that drive our value proposition.l Builds processes for the flow of information and regulatory intelligence within organization APAC.l Definition of processes to implement upcoming regulatory needs and requirements.l Support regulatory expertise and consultation for customer regulatory inquiries.l Closely work with global regulatory surveillance & advocacy team and related regulatory subject matter experts to link the local advocacy activities with global advocacy activities.l Monitor competitor approach regarding regulatory requirements.l Take care of regulatory responsibilities in Nantong project. Qualifications:Education and Languages:² Master / Ph.D. in life sciences or related science/engineering background with a strong emphasis in biologics.² Fluent in Chinese & English (verbal and written) is required. Professional Skills and Experiences:² Minimum of 3 to 5 years of relevant industry experience and/or regulatory affairs related to biopharmaceutical products, pharmaceutical substances and process materials.² Knowledgeable of CFDA drug regulations and regulatory landscape of other important country/regions (eg. China, Japan, South Korea, EU, US)² Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, aseptic processing and validation procedures.² Knowledge of regulations for Advanced Therapeutic Medicinal Products (cell, gene therapy).² Knowledge/experience for regulations concerning complex biologics (i.e., monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture.² Experience working in a global, matrix environment. Personal Skills and Competencies:² Strong organizational and time management skills.² Good project management skills.² Ability to train and educate others.² Effective management by influence.² Some experience in thought leadership.² Ability to work in multi-cultural teams.² Good listening skills with the ability to analyze and respond to given situations quickly and effectively.² Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.² Ability to indirectly influence other organizations and cultures.² Proficient in MS Office Software (Word, Excel, PowerPoint, Project).² Able and willing to travel frequently. 职能类别： 药品注册
联系方式
上海浦东张江
公司信息
北京外企德科人力资源服务上海有限公司（简称 FESCO Adecco 外企德科）是中国人力资源服务行业最具竞争力和品牌价值的FESCO与全球人力资源服务行业领航者Adecco成立的一家中外合资人力资源服务企业，为企业及个人提供业务外包、人事服务、招聘猎头和员工福利等相关人力资源解决方案。 成立于1979年，FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质，是中国人力资源服务行业的领跑者，Adecco则是全球人力资源行业的巨头，服务网络遍布全球60多个国家和地区。FESCO Adecco成立后，双方通过优势互补，整合了客户资源，依托全球化的资源和服务平台，融合本土网络优势，扩大了业务范围，为客户提供全方位的业务流程外包（BPO）、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展，并且在浙江、重庆、深圳、苏州设立了分支机构。目前，FESCO Adecco在中国每天服务达100万名员工，服务客户近12,000家。 FESCO Adecco致力于成为最专业的人力资源全面解决方案提供商，成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门，推动中国乃至全球的人力资源外包产业的健康发展。
