Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $180k - $205k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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

• 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

🎯 Requirements

• 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

🏖️ Benefits

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