小分子药学注册实习生（务必上传附件简历）
招聘时间
即日起 至 2026-06-29
招聘单位
百济神州
所在地区
苏州
工作地点
江苏省/苏州市/吴中区 工业园区金海路29号
学历要求
本科
实习时长
每周4天，每天6小时
职责描述
General Description:
This intern, Regulatory CMC will support/assist in the authoring and overall process of regulatory CMC submissions that conform to regional and international regulatory submission requirements and internal document standards, while meeting project timelines. The regulatory CMC documents include, but are not limited to, Reginal Information, DSURs, Annual reports, IMPD, and CTD Quality related sections of INDs, NDAs, BLAs, MAAs, amendments and other regulatory submission dossiers.
Essential Functions of the Job:
• Works effectively within the Global Regulatory CMC Small Molecule department and with cross-functional groups to assist in the local regulatory CMC dossiers preparation, and helps to ensure consistency between related documents
• Responsible for ensuring that assigned documents undergo Quality Control (QC) reviews and/or Quality Assurance (QA) audits before approval, and that documents are routed correctly through the appropriate review and approval cycles (e.g. Rest of World filing documents)
• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables (e.g., track the Quality document usages for different regions/countries with appropriate version control in electronic content management systems)
• Collaborate within the Regulatory CMC group to develop and maintain document authoring processes, standards, and tools (e.g., SOPs, Work Instructions, templates, style guide, etc.)
• Assigned other tasks such as SOP/WI Taskforce contribution, RA intelligence and competitor information etc.
• Ensure the compliance of Company Internal Policy/ system/ database/ responsible projects and local regulation compliant behavior.
Computer Skills: Microsoft 360
This intern, Regulatory CMC will support/assist in the authoring and overall process of regulatory CMC submissions that conform to regional and international regulatory submission requirements and internal document standards, while meeting project timelines. The regulatory CMC documents include, but are not limited to, Reginal Information, DSURs, Annual reports, IMPD, and CTD Quality related sections of INDs, NDAs, BLAs, MAAs, amendments and other regulatory submission dossiers.
Essential Functions of the Job:
• Works effectively within the Global Regulatory CMC Small Molecule department and with cross-functional groups to assist in the local regulatory CMC dossiers preparation, and helps to ensure consistency between related documents
• Responsible for ensuring that assigned documents undergo Quality Control (QC) reviews and/or Quality Assurance (QA) audits before approval, and that documents are routed correctly through the appropriate review and approval cycles (e.g. Rest of World filing documents)
• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables (e.g., track the Quality document usages for different regions/countries with appropriate version control in electronic content management systems)
• Collaborate within the Regulatory CMC group to develop and maintain document authoring processes, standards, and tools (e.g., SOPs, Work Instructions, templates, style guide, etc.)
• Assigned other tasks such as SOP/WI Taskforce contribution, RA intelligence and competitor information etc.
• Ensure the compliance of Company Internal Policy/ system/ database/ responsible projects and local regulation compliant behavior.
Computer Skills: Microsoft 360
