Kyverna is seeking a strategic Senior Director, European Regulatory Affairs to lead our regulatory efforts in Europe. This role will play a crucial part in shaping and executing regulatory strategies specifically tailored to the European market, with a strong focus on advanced therapy medicinal products (ATMPs), Pediatric Investigation Plans (PIPs), and expedited approval pathways, such as PRIME. We are looking for candidates with a proven track record in European regulatory affairs and a deep understanding of regional regulatory requirements.

Title: Sr. Director, European Regulatory Affairs

Reports to: Chief Regulatory Officer

Location: US Remote (Eastern or Central time zone preferred)

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.
Regulatory Submissions for Europe:
• 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.
Expertise in ATMPs and PIPs:
• 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.
Expedited Approval Pathways:
• 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.
Quality and Compliance:
• 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.
Regulatory Industry knowledge:
• 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.

Requirements

• Bachelor's in a relevant scientific field. Advanced degree highly preferred.
• 15+ years of industry experience within the biotechnology or pharmaceutical sector. Cell therapy experience highly preferred.
• 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.

The base salary range for candidates residing in the US for this position is $245,000 to $285,000 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 that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data.