Director of European Regulatory Affairs

Location

Work from home | India

Job description

Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the 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.

Kyverna is seeking an experienced and strategic Director of 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.

Responsibilities

• 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 advanced therapy medicinal products (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 Priority Medicine's (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 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 and interpersonal skills, with the ability to collaborate effectively in cross-functional teams.
• Adaptability to a dynamic and evolving European regulatory environment.

The salary range (170,000 - 190,000 Euros) is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.

Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

Job tags

Salary