Senior Manager, CMC Regulatory Affairs

Kyverna Therapeutics Overview:

Kyverna Therapeutics is a clinical-stage cell therapy company dedicated to engineering innovative therapies for autoimmune diseases. Our therapeutic platform utilizes advanced T cell engineering and synthetic biology technologies to suppress and eliminate autoreactive immune cells, addressing the root cause of autoimmune and inflammatory diseases. Join us in shaping the future of cell therapy and transforming the treatment landscape for autoimmune diseases.

Job Opportunity: Senior Manager/Associate Director, CMC Regulatory Affairs

Kyverna is actively seeking a Senior Manager/Associate Director with expertise in cell and gene therapy, particularly CAR T therapy. This pivotal role involves developing Regulatory CMC strategies, leading submissions, and engaging with health authorities. If you have 3-5+ years of direct CMC Regulatory Affairs experience, we invite you to contribute to the development and commercialization of Kyverna’s groundbreaking CAR T cell therapies.

Responsibilities:

• Support global Regulatory CMC strategies for Kyverna’s CAR T therapies, ensuring alignment with corporate objectives 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.
• Identify required documentation and address content, quality, or timeline issues for global submissions.
• Work with Quality Assurance and CMC teams to ensure adherence to Good Manufacturing Practices (GMP) and regulatory compliance.
• Provide regulatory review and impact assessment of proposed Change Control records.
• Represent Regulatory CMC in cross-functional project teams.
• Proactively communicate Regulatory CMC strategies, risks, and key issues throughout the life cycle to project teams and stakeholders.
• Other duties as assigned.

Qualifications:

• Bachelor’s or advanced degree in a relevant scientific field.
• Minimum 3-5 years of CMC Regulatory Affairs experience with expertise in cell and gene therapy, preferably CAR T therapy.
• Proficiency in global Regulatory CMC requirements and guidelines for cell and gene therapies.
• Proven experience in regulatory submission and approval processes, handling complex CMC regulatory issues.
• Strong attention to detail, organizational skills, and project management abilities.
• Exceptional communication and interpersonal skills for effective collaboration 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.

Salary and Benefits:

The salary range for this position is $165,000 – $195,000 USD annually. This estimate may vary based on factors such as education, experience, and skills. The position is eligible for bonus, benefits, and participation in the Company’s stock option plan.

Kyverna is an Equal Opportunity Employer, committed to equal employment opportunity for all employees, without discrimination based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other legally protected status. EOE/AA/Vets

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