Senior Director, Regulatory Advertising & Labeling - Remote

Kyverna Therapeutics; United States; Remote; USD 270,000 - 290,000; Full time

Benefits offered by this job

Annual bonus

Equity

Stock plan

Benefits

Job summary

Kyverna Therapeutics seeks a Senior Director of Advertising, Promotion and Labeling to lead regulatory strategy for all promotional materials and product labeling. This remote role reports to the SVP, Chief Regulatory Officer and supports global labeling efforts with cross-functional teams.

The position requires 10+ years in biopharma regulatory roles, with expert knowledge of FDA rules, OPDP, and labeling. West Coast hours preferred; travel ~20%.

Qualifications

• 10+ years of biopharmaceutical regulatory experience, including at least 7 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; growth-stage biotech experience preferred
• Strong leadership, scientific judgment, communication, and project management skills, with a collaborative, solutions-oriented approach
• Experience with Veeva PromoMats or similar systems
• Outstanding interpersonal and communication (written and verbal) skills

Responsibilities

• Serve as regulatory lead and approver for promotional and medical review committees, providing practical, risk-based guidance on claims, supporting evidence, fair balance, and multichannel communications
• Provide strategic, proactive regulatory guidance on the development of all promotional, advertising, and educational materials across all channels to ensure fair balance and consistency with USPI
• Lead all interactions with the US FDA OPDP and APBL, including pre-submission requests for advisory comments and managing responses to enforcement letters
• Collaborate with Global Regulatory Leads on labeling negotiations with Health Authorities, ensuring commercial objectives are supported by labeling
• Direct development and maintenance of core, U.S., and patient labeling; lead cross-functional labeling alignment and global implementation
• Establish and improve review processes, SOPs, systems, and training; monitor regulatory guidance and enforcement trends to mitigate risk
• Develop and execute strategic global labeling implementation plans to incorporate new safety and efficacy data across markets
• Monitor the regulatory landscape to proactively update internal policies and advise leadership on risk mitigation
• Build and mentor the Ad/Promo and Labeling team, oversee vendors, and manage budgets and resources
• Partner with Commercial, Medical Affairs, Legal, and Compliance to enable compliant communications
• Travel approximately 20%

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Project management

Communication

FDA regulatory know-how

Veeva PromoMats

Education

BS/MS in life sciences

Tools

Veeva PromoMats

Job description

Kyverna Therapeutics seeks a Senior Director of Advertising, Promotion and Labeling to lead regulatory strategy for all promotional materials and product labeling. This remote role reports to the SVP, Chief Regulatory Officer and supports global labeling efforts with cross-functional teams.

The position requires 10+ years in biopharma regulatory roles, with expert knowledge of FDA rules, OPDP, and labeling. West Coast hours preferred; travel ~20%.