Associate Director, CMC Regulatory Affairs
Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies 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 help transform how autoimmune diseases are treated.
Kyverna is seeking an experienced and passionate Associate Director, CMC Regulatory Affairs with a strong background in cell and gene therapy, preferably CAR T therapy. This position is responsible for providing Regulatory CMC strategies and leading the preparation of submissions and health authority interactions. We are looking for candidates with 3-5+ years of direct CMC Regulatory Affairs experience who are eager to contribute to the development and commercialization of Kyverna’s innovative CAR T cell therapies.
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.
Qualifications:
- Bachelor's or advanced degree in a relevant scientific field.
- Minimum 3-5+ 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.