Director of European Regulatory Affairs

March 29

Kyverna Therapeutics

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Taming Autoimmunity™

cell therapy • autoimmune • lupus

51 - 200

💰 $85M Series B on 2022-01

Description

• Lead the development and execution of regulatory strategies for Europe, ensuring alignment with corporate objectives and timelines. • Collaborate on planning and coordinating regulatory submissions and interactions with European health authorities. Regulatory Submissions for Europe: • Prepare, 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 ATMPs. • 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 PRIME scheme. • Collaborate closely with cross-functional teams to integrate expedited pathway considerations into 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 Intelligence: • 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 or advanced degree in a relevant scientific field. • Minimum of 5-7 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 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 and interpersonal skills, with the ability to collaborate effectively in cross-functional teams. • Adaptability to a dynamic and evolving European regulatory environment.

Benefits

• Be at the forefront of cell therapy innovation • Join a team of scientists, industry veterans, and healthcare visionaries • Opportunity to transform how autoimmune diseases are treated