Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling

🕒 Outubro 23

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $180.000 - $205.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 3%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 18 dias.
• As vagas desta empresa costumam ser preenchidas em 41 dias.

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Kyverna Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $85.000.000 Series B em 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics é uma empresa biofarmacêutica centrada no paciente e em estágio clínico, focada no desenvolvimento de terapias celulares para pacientes que sofrem de doenças autoimunes. A empresa está na vanguarda das terapias com células CAR T, aproveitando o poder transformador das células T para potencialmente proporcionar remissão sustentada e sem tratamento para condições autoimunes. O principal candidato a terapia com células CAR T da Kyverna, o KYV-101, está avançando em ensaios clínicos visando várias doenças autoimunes, incluindo esclerose múltipla, miastenia grave, esclerose sistêmica e nefrite lúpica. Seu pipeline apresenta terapias inovadoras com receptores de antígenos quiméricos (CAR) T-cells em formatos autólogos e alogênicos voltados para doenças autoimunes mediadas por células B.

Descrição

• Execute regulatory oversight for advertising, promotion, medical communications, and product labeling from pre-launch planning through lifecycle management • Develop and execute regulatory strategy for product communications and core labeling • Ensure commercial and non-promotional materials, core labeling, and local product labeling comply with US FDA, EMA, and other relevant global regulations • Serve as regulatory lead for promotional and medical review committees • Provide risk-based guidance on claims, supporting evidence, fair balance, and multichannel communications • Guide development of promotional, advertising, and educational materials across print, digital, social media, speaker programs, and formulary communications • Lead interactions with US FDA OPDP and, where applicable, APLB • Collaborate with Global Regulatory Leads on labeling negotiations with Health Authorities • Direct development and maintenance of core, U.S., and patient labeling • Establish and improve review processes, SOPs, systems, and training • Monitor regulatory guidance, enforcement trends, competitive landscape, and new safety and efficacy data • Develop and execute global labeling implementation plans • Oversee vendors and manage budgets and resources • Partner with Commercial, Medical Affairs, Legal, and Compliance • Travel approximately 20% • Reports to SVP, Chief Regulatory Officer

🎯 Requisitos

• BS or MS with requisite experience • 8+ years of biopharmaceutical Regulatory experience, including at least 6 years of advertising and promotion or equivalent experience • Expertise in FDA promotional regulations, labeling, MLR review, promotional submissions, and OPDP interactions • Demonstrated product launch and lifecycle management experience • Strong leadership, scientific judgment, communication, and project management skills • Experience with Veeva PromoMats or similar systems • Outstanding interpersonal and communication (written and verbal) skills • History of providing creative solutions to Commercial and Medical Affairs teams with superior judgment and a balanced, realistic understanding of issues • Advanced life sciences or medical degree (MD, PhD, PharmD) preferred • Growth-stage biotech experience preferred

🏖️ Benefícios

• Annual bonus eligibility • Equity • Benefits • Participation in the Company’s stock plan

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