Manager of Regulatory Affairs, Consultant (Fully Remote)

Kyverna Therapeutics; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.

The Regulatory Affairs role involves contributing to regulatory strategies, coordinating submissions, and handling inquiries from health authorities in the United States.

Qualifications

• Bachelor's or advanced degree in a relevant scientific field.
• Minimum of 2-5+ years in Regulatory Affairs within biotech or pharma.
• Experience with cell or gene therapy regulatory affairs and CTD/eCTD.

Responsibilities

• Contribute to development and execution of regulatory strategies aligned with corporate objectives.
• Assist in planning and coordinating regulatory submissions and health authority interactions.
• Prepare and coordinate responses to queries from health authorities.

Skills

Regulatory affairs

CTD/eCTD

Education

Bachelor's or advanced degree in a relevant scientific field

Job description

• Contribute to the development and execution of regulatory strategies aligned with corporate objectives.
• Assist in planning and coordinating regulatory submissions and health authority interactions.
• Prepare and coordinate responses to queries from health authorities.

Requirements:

• Bachelor's or advanced degree in a relevant scientific field.
• Minimum of 2-5+ years in Regulatory Affairs within biotech or pharma.
• Experience with cell or gene therapy regulatory affairs and CTD/eCTD.

About Kyverna:

• Patient-centered, clinical-stage biopharmaceutical company developing cell therapies.
• Focus on transforming treatment of autoimmune diseases through advanced T cell engineering.

Kyverna Therapeutics

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.