Manager, Regulatory Affairs
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
Kyverna is seeking an experienced and driven Manager of Regulatory Affairs to join our regulatory team. This role is pivotal in shaping and executing regulatory strategies for our innovative therapies. We are looking for candidates with a proven track record in Clinical/Nonclinical Regulatory Affairs within the biotechnology or pharmaceutical sector.
Responsibilities:
Regulatory Strategy:
- Contribute to the development and execution of regulatory strategies aligned with corporate objectives and timelines.
- Assist in planning and coordinating regulatory submissions and interactions with health authorities.
Regulatory Submissions:
- Manage the preparation, review, and submission of all components of regulatory submissions including INDs/CTAs and amendments, BLAs, annual reports, safety reports, etc.
- Prepare and coordinate company responses to queries from health authorities.
- Ensure regulatory documents are compliant with global regulatory requirements and guidelines.
Quality and Compliance:
- Collaborate with Quality Assurance and Regulatory teams to ensure adherence to GXP regulations and regulatory compliance.
- Support regulatory inspections and audits as needed.
Cross-Functional Collaboration:
- Collaborate with cross-functional teams, including Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other relevant departments, to align regulatory strategies with organizational goals.
- Serve as regulatory lead for study-level management teams.
Regulatory Intelligence:
- Assess changes in the regulatory environment and effectively communicate their impact on our product development strategy.
Requirements:
- Bachelor's or advanced degree in a relevant scientific field.
- Minimum of 2-5+ years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector.
- Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs.
- Experience with cell or gene therapy regulatory affairs.
- Experience with CTD/eCTD and life cycle management.
- High attention to detail, very strong organizational skills, and project management capabilities.
- Effective communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams.
- Ability to adapt to a dynamic regulatory environment.
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