RACMC Manager-上海

该职位来源于猎聘 岗位职责： RACMC on cross-functional project teams, this individual will work on developing and executing phase-appropriate CMC regulatory strategies, reviewing CMC information and data, authoring CMC submissions (incl. global core CTD dossier in English), and interacting with Health Authorities to meet the aggressive urgent submission timelines for the assigned projects, interacting with China national testing agency (e.g NIFDC). The individual will also contribute to regulatory process optimizations on relevant topics. 资历要求：

• Minimum of 5 years of experience in the pharmaceutical industry, and minimum of 3 years of experience in RACMC with emphasis on late stage CMC drug development and marketing authorization applications on chemical drug and/or biologics in China. Prefers biopharmaceutical or analytical background, with good understanding of Chinese specific HA requirements.
• Good project management skills and interpersonal skills is preferred.
• Successful track record in preparation, management of review and approval of IND/NDA with Health Authority (HA), with writing ability for both China specific documents and CTD (in EN/CN). Prefer having experience of working in global environment in interdisciplinary teams