Associate Director, Regulatory Affairs

Summary

Join Kyverna Therapeutics, a clinical-stage biopharmaceutical company, as an Associate Director of Regulatory Affairs. Contribute to the development and implementation of regulatory strategies, prepare and review regulatory documents (INDs, BLAs, MAAs, etc.), and ensure compliance with global regulatory requirements. Collaborate with cross-functional teams across Clinical, Clinical Operations, Quality Assurance, Manufacturing, and more. Monitor regulatory trends and provide strategic guidance. This role requires a Bachelor's or advanced degree in a relevant scientific field and 9+ years of experience in Regulatory Affairs within the biotechnology or pharmaceutical sector. The position offers a competitive salary, bonus, benefits, and participation in the company's stock option plan. Location is Emeryville, CA with hybrid or remote options.

Requirements

• Bachelor's or advanced degree in a relevant scientific field
• 9+ years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector
• Highly experienced in EU clinical trial applications
• Proficiency in global regulatory requirements and guidelines
• Experience in preparing regulatory submissions, including INDs, and MAAs
• High attention to detail, very 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

Responsibilities

• Contribute to the development and implementation of regulatory strategies aligned with corporate goals and timelines
• Assist in planning and coordinating regulatory submissions and interactions with health authorities
• Assist in preparation for FDA Advisory Committee meeting
• Prepare, review, compile, and archive regulatory documents, including but not limited to Investigational New Drug (IND) applications, Biologics License Applications (BLA), Regenerative Medicine Advanced Therapy (RMAT) designations, Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), Orphan Drug Designations (ODDs), Pediatric Investigational Plans (PIPs), SUSAR reports, and Development Safety Update Reports (DSURs)
• Regulatory Lead in preparation of labeling and USPI
• Ensure all submissions meet global regulatory requirements and are in full compliance with applicable guidelines
• Apply regulatory knowledge to provide strategic guidance and support cross-functional regulatory planning
• Monitor regulatory trends, evolving requirements, and industry best practices to inform internal processes
• Partner with Quality Assurance and Regulatory Affairs to ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards
• Support preparation for and participation in regulatory inspections and audits
• Work closely with teams across Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other functions to ensure regulatory alignment with overall development objectives
• Maintain awareness of changes in the global regulatory landscape affecting company products
• Evaluate the potential impact of new or revised regulations and communicate implications for development strategies and timelines

Benefits

• Bonus
• Benefits
• Participation in Company’s stock option plan