[Hiring] Manager of Regulatory Affairs @Kyverna Therapeutics

Role Description

Kyverna is seeking an experienced and driven Manager of Regulatory Affairs to join our regulatory team in a Contract position. This role is pivotal in shaping and executing regulatory strategies for our innovative therapies.

• 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.

Qualifications

• 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, 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.

Requirements

• Remote (West Coast hours preferred)
• Duration: Six months
• Hours: 40/hrs per week
• Hourly rate: $75 to $85/hr