Manager – Regulatory Affairs, Consultant

Job not on LinkedIn

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $75 - $85 / hour

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• 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. • Manage the preparation, review, and submission of regulatory submissions, including INDs/CTAs and amendments, BLAs, annual reports, and safety reports. • Prepare and coordinate company responses to health authority queries. • Ensure regulatory documents comply with global regulatory requirements and guidelines. • Collaborate with Quality Assurance and Regulatory teams to ensure adherence to GXP regulations and regulatory compliance. • Support regulatory inspections and audits as needed. • Collaborate with Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other relevant departments. • Serve as Regulatory lead for study-level management teams. • Assess changes in the regulatory environment and communicate their impact on product development strategy. • Report to the Executive Director, Regulatory Affairs.

🎯 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, 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. • West Coast hours preferred.