Regulatory Submissions Ass Manager II
职位描述 我们正在寻找监管提交 Ass Manager II,以通过欧洲及其他地区的高质量监管提交支持全球和区域临床试验。该角色在确保及时批准，监管合规以及成功研究启动方面发挥着关键作用，重点放在欧盟临床试行管理 (CTR) 和 CTIS 运营上。你将在矩阵中工作，面向客户环境，与项目团队，初创公司领导者，当地监管小组和外部当局密切合作。主要责任 ·拥有并管理分配临床试用机构的监管机关 (RA),IRB/EC 和第三方机构的提交，包括：·提交战略，规划和时间表管理 ·跟踪项目里程碑 (GL, RTE) 的批准 ·在定义的时间内协调对当局询问的回应 ·通过 CTIS 进行 EUCTR 提交的领导或支持，包括：·编制，提交和维护 CTIS 应用程序 ·管理 CTIS 用户访问并当需要时作为 CTIS 备份工作 ·咨询内部团队关于 CTR/CTIS 流程和期望 ·准备，审查和质量检查核心监管方案以及国家特定提交方案 ·确保所有交付内容符合适用的规定，指导，SOP 和客户要求 · 通过保持最新的全球和欧盟监管要求知识，向项目团队提供监管指导；· 与当地团队与监管机构，伦理委员会和第三机构沟通或支持他们·识别并主动升级时间表，质量或批准风险；· 支持审计，检查和解决结果；• 促进进程改进举措，包括 SOP 开发和优化；· 辅导年轻团队成员以及支持整体团队能力建设所需资格和经验；· 生物科学学士学位或相关领域 （或同等专业）· 需要在制药，生物技术或 CRO 领域开展监管事务，监管提交或临床试验工作的最低4年经验 ·与欧盟 CTR 和 CTIS 相关实践经验，包括：·编写和提交申请 CTIS ·管理 CTIS 工作流程，时间表和用户访问 ·回答有关 CTIS 的权威问题 ·对 RA,IRB/EC 以及第三机构提交过程有充分的了解 ·支持全球或区域的经验 c
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Job Description
We are looking for a Regulatory Submissions Ass Manager II to support global and regional clinical trials through high‑quality regulatory submissions across Europe and beyond. This role plays a critical part in ensuring timely approvals, regulatory compliance, and successful study start‑up, with a strong focus on EU Clinical Trial Regulation (CTR) and CTIS operations.
You will work in a matrix, client‑facing environment, collaborating closely with project teams, start‑up leads, local regulatory teams, and external authorities.
Key Responsibilities
- Own and manage Regulatory Authority (RA), IRB/EC, and Third Body submissions for assigned clinical trials, including:
- Submission strategy, planning, and timeline management
- Tracking approvals against project milestones (GL, RTE)
- Coordinating responses to authority queries within defined timelines
- Lead or support EU CTR submissions via CTIS, including:
- Preparation, submission, and maintenance of CTIS applications
- Managing CTIS user access and acting as CTIS back‑up when required
- Advising internal teams on CTR/CTIS processes and expectations
- Prepare, review, and quality‑check core regulatory packages and country‑specific submission packages
- Ensure all deliverables comply with applicable regulations, guidance, SOPs, and client requirements
- Provide regulatory guidance to project teams by maintaining up‑to‑date knowledge of global and EU regulatory requirements
- Liaise with or support local teams in communications with Regulatory Authorities, Ethics Committees, and Third Bodies
- Identify and proactively escalate risks to timelines, quality, or approvals
- Support audits, inspections, and resolution of findings
- Contribute to process improvement initiatives, including SOP development and optimization
- Mentor junior team members and support overall team capability building
Required Qualifications & Experience
- Bachelor’s degree in Life Sciences or a related field (or equivalent experience)
- Minimum 4 years of experience in Regulatory Affairs, Regulatory Submissions, or Clinical Trial Start‑Up within pharma, biotech, or CRO
- Hands‑on experience with EU CTR and CTIS is required, including:
- Preparing and submitting applications in CTIS
- Managing CTIS workflows, timelines, and user access
- Responding to CTIS‑related authority questions
- Solid understanding of RA, IRB/EC, and Third Body submission processes
- Experience supporting global or regional clinical trials
- Strong organizational skills with the ability to manage multiple submissions and deadlines
- Confident communicator able to work with cross‑functional and client stakeholders
Learn more about our EEO & Accommodations request here.
Originally posted on Himalayas