Regulatory Affairs, Consultant

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and helping transform how autoimmune diseases are treated.

Kyverna is seeking an experienced and driven Regulatory Affairs Consultant to join our regulatory team in a Contract position. This role is pivotal in shaping and executing regulatory strategies for our innovative therapies. We are looking for candidates with a proven track record in Clinical/Nonclinical Regulatory Affairs within the biotechnology or pharmaceutical sector.

Title: Regulatory Affairs Consultant

Reports to: Executive Director, Regulatory Affairs

Location: Remote (West Coast hours preferred)

Duration: Six months

Hours: 40/hrs per week

Hourly rate: $75 to $85/hr

Responsibilities

Regulatory Strategy:

• 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.

Regulatory Submissions:

• Manage the preparation, review, and submission of all components of regulatory submissions including INDs/CTAs and amendments, investigator submissions, BLAs, annual reports, safety reports, briefing documents, etc.

• Lead regulatory correspondence with global CROs and vendors, tracking deliverables, managing timelines, and informing country-specific submission strategy with alignment with GRL and regional leads.

• Prepare and coordinate company responses to queries from global health authorities in collaboration with cross functional subject matter experts and senior leadership.

• Ensure regulatory documents are compliant with global regulatory requirements and guidelines.

Quality and Compliance:

• Collaborate with Quality Assurance and Regulatory teams to ensure adherence to GXP regulations and regulatory compliance.

• Support regulatory inspections and audits as needed.

• Regulatory Document Archival of Health Authority correspondence, acknowledgements, submission packages, RFIs, approvals/decisions, official translations.

Cross-Functional Collaboration:

• 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 and/or Representative for study-level management teams and meetings with global vendors and CROs.

Regulatory Intelligence:

• Assess changes in the regulatory environment and effectively communicate their impact on our product development strategy.

Requirements

• • 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 preferred.

  • EU C TA / CTIS experienced

  • 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.