法规事务总监，CMC
Director, Regulatory Affairs, CMC
BrainChild Bio 正在寻找一位监管事务、CMC 部门总监，以支持我们在临床阶段细胞治疗项目中实施全球监管 CMC 策略。BrainChild Bio 是一家以儿童为先的公司，专注于开发创新细胞疗法，用于治疗严重疾病患者，此职位在确保交付的每项产品都符合最高质量、安全性和可靠性标准方面起着关键作用。
监管事务、CMC 部门总监负责在多个产品上执行全球 CMC 监管策略。该职位参与监管 CMC 文件的规划、准备和提交工作。个人需要向项目团队提供指导，并负责准备与 CMC 和质量相关的机构通信及监管申请，确保所有适用的监管要求得到考虑并适当纳入每个项目的生命周期中。
理想的候选人注重细节，高度有条理，并且希望通过直接改善患者生活的机会来获得动力。此职位提供了与开发团队以及相关外部方（包括合同制造组织、专家顾问和全球卫生当局）跨职能合作的机会。
职责：
- 负责监管 CMC 提交文件的所有运营和生命周期管理方面的工作（例如，IND、IMPD、BLA、MMA、变更、修订），支持细胞治疗开发项目。
- 制定并执行与项目目标、监管要求和整体业务战略一致的全球监管 CMC 策略。
- 作为跨职能项目团队中的监管 CMC 主导者，为细胞治疗开发和生命周期管理提供战略监管指导。
- 撰写、审核并协调模块 3（M3）内容，确保全球监管提交文件（例如，美国、欧盟和其他国际卫生当局）的一致性、质量和一致性。
- 通过正式的变更控制流程评估 CMC 变更的监管影响，并制定和执行适当的提交策略。
- 主动识别 CMC 监管风险，预判卫生当局的问题，并制定缓解和应急策略以支持成功结果。
- 领导或参与与卫生当局的互动，准备简报资料和技术文件
查看英文原文
BrainChild Bio is seeking a Director, Regulatory Affairs, CMC, to support implementation of the global regulatory CMC strategy across our clinical-stage cell therapy programs. BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases, and this role plays a critical part in ensuring that every product delivered meets the highest standards of quality, safety, and reliability.
The Director, Regulatory Affairs, CMC is accountable for executing on the global CMC regulatory strategies across multiple products. This role contributes to the planning, preparation, and submission of regulatory CMC documentation. The individual will be expected to provide guidance to the program teams and will be responsible for preparation of CMC and Quality related agency correspondences and regulatory applications ensuring all applicable regulatory requirements are considered and appropriately incorporated into the lifecycle of each program.
The ideal candidate is detail-oriented, highly organized, and motivated by the opportunity to make a direct impact on patients’ lives. This role offers the opportunity to work cross-functionally with development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, and global health authorities.
Responsibilities:
- Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting cell therapy development programs.
- Develop and execute global regulatory CMC strategies that align with program objectives, regulatory requirements, and overall business strategy.
- Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development and lifecycle management.
- Author, review, and coordinate Module 3 (M3) content, ensuring consistency, quality, and alignment across global regulatory submissions (e.g., US, EU, and other international health authorities).
- Evaluate the regulatory impact of CMC changes through formal change control processes and define and execute appropriate filing strategies.
- Proactively identify CMC regulatory risks, anticipate Health Authority questions, and develop of mitigation and contingency strategies to support successful outcomes.
- Lead or contribute to interactions with health authorities by preparing briefing packages, technical justifications, responses to information requests, and regulatory meeting support.
- Collaborate cross‑functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines.
- Drive continuous improvement and best‑practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment.
Qualifications:
- Bachelor’s degree in scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field).
- 8+ years of Regulatory CMC and/or drug development experience, including direct experience supporting FDA-regulated cell therapy products.
- Familiarity with GMP principles and documentation practices.
- Strong attention to detail, organizational skills, and ability to manage multiple priorities.
- Effective communication skills and ability to work cross-functionally.
- Ability to thrive in a fast-paced, mission-driven, small company environment and adapt to shifting priorities.
- Occasional travel required.