Note: The job is a remote job and is open to candidates in USA. Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. The Manager of Regulatory Affairs, Consultant contributes to regulatory strategy and manages submissions, health authority interactions, compliance support, and cross-functional regulatory coordination.

Responsibilities

• Contribute to the development and execution of regulatory strategies aligned with corporate objectives and timelines
• Assist in planning and coordinating regulatory submissions and interactions with health authorities
• Manage the preparation, review, and submission of all components of regulatory submissions including INDs/CTAs and amendments, BLAs, annual reports, safety reports, etc
• Prepare and coordinate company responses to queries from health authorities
• Ensure regulatory documents are compliant with global regulatory requirements and guidelines
• Collaborate with Quality Assurance and Regulatory teams to ensure adherence to GXP regulations and regulatory compliance
• Support regulatory inspections and audits as needed
• Collaborate with cross-functional teams, including Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other relevant departments, to align regulatory strategies with organizational goals
• Serve as Regulatory lead for study-level management teams
• Assess changes in the regulatory environment and effectively communicate their impact on our product development strategy

Skills

• Candidates with a proven track record in Clinical/Nonclinical Regulatory Affairs within the biotechnology or pharmaceutical sector
• Bachelor's or advanced degree in a relevant scientific field
• Minimum of 2-5+ years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector
• Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs
• Experience with cell or gene therapy regulatory affairs
• Experience with CTD/eCTD and life cycle management
• High attention to detail, 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

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