Senior Director, European Regulatory Affairs

Summary

Join Kyverna Therapeutics, a clinical-stage biopharmaceutical company, as the Senior Director of European Regulatory Affairs. Lead and execute regulatory strategies in Europe, focusing on advanced therapy medicinal products (ATMPs), Pediatric Investigation Plans (PIPs), and expedited approval pathways like PRIME. This crucial role involves overseeing regulatory submissions, ensuring compliance, and collaborating with European health authorities. The ideal candidate possesses extensive experience in European regulatory affairs, particularly with ATMPs, and a proven track record of successful regulatory submissions. The position is remote within the US (Eastern or Central time zone preferred).

Requirements

• Bachelor's in a relevant scientific field
• 15+ years of industry experience within the biotechnology or pharmaceutical sector
• Expertise in European regulatory requirements and guidelines for biopharmaceutical products, with a strong emphasis on advanced therapy medicinal products (ATMPs)
• Proven experience in preparing European-specific regulatory submissions, such as CTAs, MAAs, and PIPs
• Strong familiarity with expedited approval pathways in Europe, including PRIME
• Strong attention to detail, organizational skills, and project management abilities
• Excellent communication, interpersonal, and leadership skills, with the ability to collaborate with and effectively lead cross-functional teams across multiple continents
• Adaptability to a dynamic and evolving European regulatory environment

Responsibilities

• Lead the development and execution of regulatory strategies for Europe, ensuring alignment with corporate objectives and timelines
• Drive the planning and coordination of regulatory submissions and interactions with European health authorities
• Oversee the preparation, review, and compile European-specific regulatory submissions, including Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), and post-approval variations
• Ensure that European regulatory documents are compliant with regional requirements and guidelines
• Utilize in-depth knowledge and experience in European regulatory affairs to provide specialized guidance and insights, particularly in the context of advanced therapy medicinal products (ATMPs)
• Leverage contacts within Regulatory Agencies and Industry working groups to influence government policies and procedures relating to ATMPs in the EU
• Lead the development and execution of Pediatric Investigation Plans (PIPs) for applicable programs, ensuring compliance with pediatric regulatory requirements
• Demonstrate proficiency in navigating and leveraging expedited approval pathways in Europe, such as the Priority Medicine's (PRIME) scheme
• Proactively identify, develop, and implement (with cross-functional teams) expedited pathway strategies to optimize regulatory strategies and activities
• Work in partnership with Quality Assurance and Regulatory teams to ensure adherence to GxP and regulatory compliance in Europe
• Support regulatory inspections and audits with a focus on European regulatory requirements
• Stay updated on evolving European regulatory requirements, industry trends, and best practices
• Assess and communicate the impact of regulatory changes in Europe on regulatory affairs activities and product development

Preferred Qualifications

• Advanced degree
• Cell therapy experience