Sr. Manager, Regulatory Operations

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values,
Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome
, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

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. This role is critical to ensuring high-quality, compliant, and timely regulatory submissions to global health authorities, including FDA, EMA, and other international agencies.

The ideal candidate brings deep hands‑on regulatory operations expertise in an IND-stage or BLA-preparing environment, thrives in fast-paced biotech settings, and partners closely with Regulatory Affairs, CMC, Clinical, and Quality teams.

Title
:
Sr. Manager, Regulatory Operations

Location
:
Remote with west coast hours

Reports to
:
Executive Director, Regulatory Operations

• 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 and
• 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.

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• 8+ years of regulatory operations experience in biotech or pharmaceutical industry.
• Demonstrated experience supporting IND-stage, BLA/MAA, and marketed product submissions.
• 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 Docu Bridge, DXC Toolbox, Lorenz eValidator). Veeva Publishing experience preferred.
• Strong document formatting expertise with hands‑on experience utilizing Regulatory document templates (Starting Point experience preferred).
• 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.

The national salary range for this position is from $145,000 to $180,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.

This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.