临床报批主管，Director of Regulatory Affairs 深圳

月薪： 20-60万/年

该公司所有职位
  • 5-7年经验
  • 硕士
  • 招1人
  • 11-09 发布
  • 五险一金
  • 定期体检
  • 带薪年假
  • 节日福利
  • 员工培训

职位描述

职位描述： Essential Functions and Responsibilities:These may include but are not limited to:-Lead and manage the submission of regulatory applications and documents, including responses to information requests, included in the company’s internal or partnered submissions-Represent Regulatory Affairs at team meeting and apply influence and negotiation skills to resolve issues-Lead and manage cross-functional meetings to drive project development results-Create and maintain regulatory timelines and track deliverables to timelines to ensure that internal and partner regulatory submission timeless are met-Develop regulatory strategy and provide strategic input and regulatory advice to project teams-Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages-Provide critical review of documents (SOPs, protocols, and reports) related to clinical, drug safety, nonclinical or manufacturing, as necessary-Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks-Assure compliance with U.S. and China regulations-Maintain knowledge of current global regulations, and guidance governing drugs and biologics in all phases of development-Work cross functionally with Clinical, safety, research, quality, manufacturing, product management, etc.   Qualifications-A minimum of a MS in life sciences with at least 5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries (an equivalent combination of education and experience may be considered)-Demonstrated experience with U.S. submissions and a working knowledge of FDA/EMA regulations, the regulators, and the approval process. Experience with European/global submissions is a plus.-Experience with oncology indications is preferred-Experience in applying regulatory knowledge to various situations and serve as a source of competitive advantage to the company-Experienced in all components of regulatory submissions including chemistry, manufacturing and control, non-clinical, and clinical documentation is further required-A record of successful U.S. submissions for biologics and drugs which include INDs, NDAs/BLAs, MAAs, Annual Reports, and Amendments-Excellent operational skills including planning, organizing and the ability to deal effectively with a variety of personnel both internally and outside the company-Sound scientific judgment, Excellent problem solving skills and quality-driven.-Demonstrated management, leadership and teamwork skills.-Excellent writing, communication, and interpretive skills-High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently-Excellent verbal and written communication skills; proficient oral and written skills in both English and Mandarin.-Enthusiasm and passion to for conducting creative scientific research.-Additional experience in a smaller biotech company is a plus. RAC certification is preferred-Software knowledge: Windows, MS Office (Outlook, Word, Excel) 职能类别： 医药技术研发管理人员 关键字： regulatory, director, 临床报批

联系方式

科技园中区科苑路15号

公司信息

深圳市塔吉瑞生物医药有限公司成立于2014年，是一家中美合资的高科技医药研发公司。公司成立之初已获得国 内著名天使机构投资，注册资金八千万元人民币。公司位于深圳市南山区科技园中区高科技孵化基地科兴科技园，已建有800多平方米的办公室和实验室. 公司将专注于国际前沿的靶向新药研发，并力争成为世界领先的靶向新药研发基地。公司创始人王义汉博士具有多年国际I类新药研发经验，是多个国际I类新药的核心发明人。公司将以王博士为核心，广纳医药界精英组成强大研发团队，开创塔吉瑞的美好未来。 塔吉瑞将发挥国际化、高科技的优势，注重培养员工严谨的科学精神，为员工提供良好的职业生涯发展规划。公司坚持以人为本的用人理念，营造和谐的用人环境，为员工提供良好的事业平台、科学的考评制度与完善的晋升机制，并建立顺畅的沟通渠道。 塔吉瑞的发展需要人才，现诚邀各路英才加入，与公司一起成长，创造辉煌！

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