Associate Director, CMC Regulatory Affairs

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.

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.