Associate Director, CMC Regulatory Affairs

Summary

Join Kyverna as an Associate Director, CMC Regulatory Affairs, contributing to the development and execution of global regulatory strategies for their CAR T therapies. This role involves leading the preparation of submissions, interacting with health authorities, and ensuring compliance with regulatory guidelines. You will collaborate with cross-functional teams, author and review CMC sections for regulatory submissions, and manage change control records. This position requires a strong background in cell and gene therapy, particularly CAR T therapy, and a proven track record in regulatory submissions and approval processes.

Requirements

• Bachelor's or advanced degree in a relevant scientific field
• 9+ years of CMC Regulatory Affairs experience with direct experience in cell and gene therapy, preferably CAR T therapy
• Expertise in global Regulatory CMC requirements and guidelines for cell and gene therapies
• Proven experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements
• Strong attention to detail, organizational skills, and project management abilities
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams
• Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment
• Adaptability to a dynamic and evolving regulatory environment

Responsibilities

• Support development and execution of global Regulatory CMC strategies for Kyverna’s CAR T therapies, ensuring alignment with corporate objectives/timelines and regulatory compliance
• Collaborate on planning and coordinating regulatory submissions and interactions with health authorities
• Author and/or review high quality CMC sections for global regulatory submissions (IND/CTA, and BLA/MAA), applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines
• Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
• Work in partnership with Quality Assurance and CMC teams to ensure adherence to Good Manufacturing Practices (GMP) and regulatory compliance
• Provide regulatory review and impact/implementation assessment of proposed Change Control records and manage the associated regulatory notifications
• Represent Regulatory CMC in cross-functional project teams
• Proactively identify and communicate Regulatory CMC strategies, risks, and key issues throughout the life cycle in a timely manner to project teams and other stakeholders
• Other duties as assigned

Benefits

This position is also eligible for bonus, benefits, and participation in Company’s stock option plan