Senior Director, European Regulatory Affairs - Remote

Overview

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 help transform how autoimmune diseases are treated.

In Short

• Lead the development and execution of regulatory strategies for Europe.
• Drive planning and coordination of regulatory submissions with European health authorities.
• Oversee preparation and review of European-specific regulatory submissions.
• Utilize knowledge in ATMPs to provide specialized guidance.
• Leverage contacts within Regulatory Agencies to influence policies.
• Lead the development of Pediatric Investigation Plans (PIPs).
• Navigate expedited approval pathways in Europe.
• Ensure adherence to GxP and regulatory compliance.
• Stay updated on European regulatory requirements and trends.
• Communicate impact of regulatory changes on product development.

Requirements

• Bachelor's in a relevant scientific field; advanced degree preferred.
• 15+ years of industry experience in biotechnology or pharmaceuticals.
• Expertise in European regulatory requirements for biopharmaceuticals.
• Experience in preparing European-specific regulatory submissions.
• Familiarity with expedited approval pathways like PRIME.
• Strong attention to detail and organizational skills.
• Excellent communication and leadership skills.
• Ability to lead cross-functional teams across continents.
• Adaptability to a dynamic regulatory environment.

Benefits

• Be part of an innovative biopharmaceutical company.
• Opportunity to shape regulatory strategies in Europe.
• Work with a team of industry veterans and experts.
• Engage in meaningful work that impacts patient care.