Kyverna Therapeutics · 6 days ago
Sr. Manager, Regulatory Operations
United States
Full-time
Remote
Senior Level, Lead/Staff
$145K/yr - $180K/yr
8+ years expKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The Senior Manager, Regulatory Operations will be responsible for the end-to-end execution and oversight of regulatory submissions across the company’s cell therapy portfolio.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Leads planning, preparation, publishing, and lifecycle management of regulatory submissions (e.g., INDs, IMPDs, amendments, annual reports, meeting packages, BLAs/MAAs)
Ensure submissions are compliant with global regulatory requirements and electronic standards (eCTD, NeeS, regional requirements)
Manage submission timelines, content readiness, and cross-functional coordination to support regulatory milestones
Leads Veeva RIM Office hours and provides business process support for Regulatory document, information, and submission management procedures
Develop, maintain, and optimize regulatory operations processes, SOPs, templates, and best practices
Performs Regulatory Submission and Correspondence archival, ensuring version control, and inspection-ready documentation
Provide support for Regulatory deliverables in GCP Inspection Readiness
Partner closely with Regulatory Affairs strategy leads, CMC, Clinical Development, Medical Writing, Quality, and external vendors
Provide regulatory operations guidance to internal teams to ensure efficient content development and submission readiness
Support health authority interactions by preparing and managing briefing packages and response submissions
Supports the evaluation and implementation of new tools or technologies to improve submission efficiency and compliance
Act as a subject matter expert in regulatory operations, advising on evolving global regulatory requirements and electronic submission standards
Drive continuous improvement initiatives to enhance submission quality, speed, and scalability
Qualification
Required
Bachelor's degree in life sciences or related field required
8+ years of regulatory operations experience in biotech or pharmaceutical industry
Demonstrated experience supporting IND-stage, BLA/MAA, and marketed product submissions
Strong knowledge of FDA, EMA, and global regulatory submission requirements
Highly organized with exceptional attention to detail and ability to manage multiple submissions in parallel
Strong communication and cross-functional collaboration skills
Comfortable operating in a fast-moving, evolving clinical-stage environment
Proactive, solutions-oriented mindset with a strong sense of ownership
Preferred
advanced degree preferred
Prior experience in cell therapy, gene therapy, or other advanced therapies highly desirable
Hands-on experience with eCTD publishing and regulatory systems (e.g., Veeva RIM, Vault, Lorenz DocuBridge, DXC Toolbox, Lorenz eValidator). Veeva Publishing experience preferred
Strong document formatting expertise with hands-on experience utilizing Regulatory document templates (StartingPoint experience preferred)
Benefits
Bonus
Benefits
Participation in Company’s stock option plan
Company
Kyverna Therapeutics
Kyverna Therapeutics is pioneering a new class of therapies and cures for serious autoimmune diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$295MKey Investors
Oxford Finance LLCNorthpond Ventures
2025-12-17Post Ipo Equity· $100M
2025-11-03Post Ipo Debt· $25M
2024-02-08IPO
Leadership Team
Marc Grasso
Chief Financial Officer
Tom Van Blarcom
Senior Vice President, Head of Research
Recent News
2026-01-16
Company data provided by crunchbase