Regulatory Affairs Manager - Remote Contract

Kyverna Therapeutics; United States; Remote; USD 103,000 - 117,000; Part time

Job summary

Kyverna Therapeutics is seeking an experienced Manager of Regulatory Affairs for a six-month contract role. This remote position supports global regulatory submissions, strategy, and interactions with health authorities, with West Coast hours preferred.

The ideal candidate has 2–5+ years in Regulatory Affairs within biotech/pharmaceuticals, CTD/eCTD experience, and a track record in cell or gene therapy regulatory programs, ensuring compliance with ICH and international requirements.

Qualifications

• Bachelor's or advanced degree in a relevant scientific field.
• 2–5+ years of industry experience in Regulatory Affairs within biotech/pharma.
• Extensive knowledge of regulatory requirements including ICH and regional requirements.
• Experience with CTD/eCTD and lifecycle management.
• Experience with cell or gene therapy regulatory affairs.
• Strong communication and interpersonal skills; ability to work cross-functionally.

Responsibilities

• Contribute to the development and execution of regulatory strategies aligned with objectives and timelines.
• Assist in planning and coordinating regulatory submissions and interactions with health authorities.
• Manage the preparation, review, and submission of regulatory submissions including INDs/CTAs, amendments, BLAs, annual reports, safety reports.
• Prepare and coordinate company responses to queries from health authorities.
• Ensure regulatory documents are compliant with global regulatory requirements and guidelines.
• Collaborate with Quality Assurance and Regulatory teams to ensure adherence to GXP regulations and regulatory compliance.
• Collaborate with cross-functional teams to align regulatory strategies with organizational goals; serve as Regulatory lead for study-level management teams.
• Assess changes in the regulatory environment and communicate their impact on development strategy.

Skills

Regulatory affairs

CTD/eCTD

Regulatory submissions

Cross-functional collaboration

Attention to detail

Communication skills

Education

Bachelor's degree or higher in a relevant scientific field

Advanced degree in a relevant scientific field

Job description

Kyverna Therapeutics is seeking an experienced Manager of Regulatory Affairs for a six-month contract role. This remote position supports global regulatory submissions, strategy, and interactions with health authorities, with West Coast hours preferred.

The ideal candidate has 2–5+ years in Regulatory Affairs within biotech/pharmaceuticals, CTD/eCTD experience, and a track record in cell or gene therapy regulatory programs, ensuring compliance with ICH and international requirements.