Manager of Regulatory Affairs, Consultant
凯佛纳疗法是一家专注于自身免疫疾病患者的细胞治疗开发的临床阶段生物制药公司。凯佛纳治疗平台利用先进的 T 细胞工程来抑制和消除自身免疫细胞在自身免疫和炎症病的起源。通过加入科学家，行业退伍军人和医疗保健愿景者并帮助改变自身免疫疾病的治疗方式，成为细胞疗法的创新最前沿。凯弗纳正在寻找一个经验丰富且有驱动力的监管事务管理人员，将加入我们的监管团队合同职位。标题：监管事务经理，咨询报告给执行董事，监管事务位置：远程 （西海岸时间优先）持续时间：六个月 每周40小时每小时 工资费：75至85美元/小时 责任监管战略：· 贡献与企业目标和时间表一致的监管策略的开发和实施。· 协助规划和协调监管提交，与卫生当局的互动。监管提交：· 管理准备，审查和提交所有包括 IND/CTA 和修正案，BLA,年度报告，安全报告等在内的监管提交组件。· 准备和协调公司对健康部门的询问的回应。·确保监管文件符合全球监管要求和指南。质量和合规：· 与质量保证和监管团队合作以确保遵守 GXP 规定和监管合规。· 根据需要支持监管检查和审计。跨职能合作：· 与临床，临床运营，质量保证，制造业，非临床，技术开发等相关部门的跨职能团队合作，以与组织目标协调监管战略。· 为研究级管理团队提供监管领导作用。
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Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and helping transform how autoimmune diseases are treated.
Kyverna is seeking an experienced and driven Manager of Regulatory Affairs to join our regulatory team in a Contract position. This role is pivotal in shaping and executing regulatory strategies for our innovative therapies. We are looking for candidates with a proven track record in Clinical/Nonclinical Regulatory Affairs within the biotechnology or pharmaceutical sector.
Title: Manager of Regulatory Affairs, Consultant
Reports to: Executive Director, Regulatory Affairs
Location: Remote (West Coast hours preferred)
Duration: Six months
Hours: 40/hrs per week
Hourly rate: $75 to $85/hr
Responsibilities
Regulatory Strategy:
- Contribute to the development and execution of regulatory strategies aligned with corporate objectives and timelines.
- Assist in planning and coordinating regulatory submissions and interactions with health authorities.
Regulatory Submissions:
- Manage the preparation, review, and submission of all components of regulatory submissions including INDs/CTAs and amendments, BLAs, annual reports, safety reports, etc.
- Prepare and coordinate company responses to queries from health authorities.
- Ensure regulatory documents are compliant with global regulatory requirements and guidelines.
Quality and Compliance:
- Collaborate with Quality Assurance and Regulatory teams to ensure adherence to GXP regulations and regulatory compliance.
- Support regulatory inspections and audits as needed.
Cross-Functional Collaboration:
- Collaborate with cross-functional teams, including Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other relevant departments, to align regulatory strategies with organizational goals.
- Serve as Regulatory lead for study-level management teams.
Regulatory Intelligence:
- Assess changes in the regulatory environment and effectively communicate their impact on our product development strategy.
Requirements
- Bachelor's or advanced degree in a relevant scientific field.
- Minimum of 2-5+ years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector.
- Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs.
- Experience with cell or gene therapy regulatory affairs.
- Experience with CTD/eCTD and life cycle management.
- High attention to detail, strong organizational skills, and project management capabilities.
- Effective communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams.
- Ability to adapt to a dynamic regulatory environment.
Originally posted on Himalayas