Director, Regulatory Affairs 苏州

月薪： 60-80万/年

该公司所有职位
  • 8-9年经验
  • 硕士
  • 招1人
  • 11-09 发布

职位描述

职位描述： Principal Duties and Responsibilities/主要职责（包括但不限于）?Responsible for oversight and direction Regulatory operations at CMAB’s Suzhou manufacturing facility.?Support Head of QA acting as interface representing Regulatory Affairs (RA) in intra company and client/customer interactions.?Advise quality operations for corporate facilities and operations to ensure compliance.?Responsible for the establishment of the functional Regulatory Affairs (RA) organization.?Implementation of corporate RA Management Systems aligned with CMAB strategic and corporate objectives spanning the following areas:?For assigned client products/projects, responsible for the independent and timely procurement and examination of the documents required for the registration, declaration of conformity and approval form the specialist departments.?The timely and independent creation of dossiers or their precursors according to the statutory and official requirements of the target countries.?Accountable for assessment of product changes within the scope of the change control process to determine the permissibility for authorization and responsible for the implementation and tracking of the approved changes, including proactive coordination.?Provide cross functional support to internal CMAB departments to ensure sustainability and continuous improvement in all compliance and quality functions.?Participate as a standing member of the Quality Management Review committee.Job Requirements/工作经验?M.Sc. Pharm degree or equivalent, fulfill the legal requirements for a Qualified Person.?Have previous experience (5 Years) as Responsible (Qualified) Person or a management role in Regulatory Affairs supporting clinical/commercial biologic manufacturing for a contract or development/MAA corporation.?Have excellent organizational skills and the ability to work on a number of projects simultaneously?Flexible and enjoy working both independently and in groups?Self-motivated, driven and have excellent ability to cooperate with internal as well as external stakeholders?Expert knowledge of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) encompassing documentation and operation of pharmaceutical facilities including C-FDA, Eudralex, PIC/S and US-FDA with focus on biological API and sterile product manufacture.?Detailed knowledge in the design, implementation and maintenance of Regulatory Operations and Systems for global compliance.?Thorough understanding of mAb development, manufacturing, and analytical process.?Demonstrated capability and enthusiasm to establish high-performance teams.?Advanced computer system and database skills.?Excellent communication skills in Chinese and English to engage with personnel from multiple disciplines and experience bases across the operations organization to facilitate cross functional communication and planning for the coordination of RA requirements and solutions across locations and countries (China, USA, etc.).?Exposure to company and facility start-up.?Strong prioritization and organization skills.?Detail oriented, flexible, self-initiative. 职能类别： 生物工程/生物制药

联系方式

东平街188号

公司信息

苏桥医药（苏州）有限公司是一家致力于抗体及融合蛋白类生物药物的研发、工艺开发、及中试生产的高科技企业，服务范围全面覆盖临床前研究、临床研究、及商业化生产阶段。总投资额为4,640万美元。 苏桥医药是苏州生物纳米科技园（BioBay）重点扶持的企业之一。苏桥在园区内的建造面积共占地7,000平方米，目标产能1期实现69批次，2期实现92批次。 苏桥将严格遵守国际主流药品监管机构的质量标准，包括CFDA、USA (21-CFR) 、EMA (Eurdralex)、PIC/S以及 WHO。苏桥交付的生产样品能够满足客户在全球多个国家临床试验申请的CMC要求。

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