Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling

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

The Senior Director, Advertising, Promotion and Labeling will lead and execute regulatory strategy for advertising, promotion, medical communications, and product labeling from pre-launch planning through lifecycle management. This is a critical leadership role responsible for developing and executing regulatory strategy for all product communications and core labeling. This leader will ensure that all commercial and non-promotional materials, as well as core and local product labeling, are compliant with US FDA, EMA, and other relevant global regulations. The role requires expert-level interpretation of complex regulatory requirements and a proven ability to lead and influence cross-functional teams to achieve both compliance and business goals.

Title :Senior Director, Advertising, Promotion and Labeling

Reports to : SVP, Chief Regulatory Officer

Location :Remote (West Coast hours preferred)

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 (print, digital, social media, speaker programs, formulary communications) to ensure fair balance and consistency with the US Prescribing Information (USPI)
• Lead all interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), 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 that commercialization objectives are adequately supported by the final approved labeling
• Direct development and maintenance of core, U.S., and patient labeling; lead cross-functional labeling alignment, global implementation, and support health authority negotiations
• 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, ensuring timely distribution and compliant use across all markets
• Monitor the competitive and regulatory landscape, including new guidance documents and enforcement actions, to proactively update internal policies and advise senior 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 effective communications consistent with approved labeling and applicable U.S. and global requirements
• Travel approximately 20%

Requirements

• BS or MS with requisite experience; advanced life sciences or medical degree (MD, Ph D, PharmD) preferred
• 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
• History of providing creative solutions to Commercial and Medical Affairs teams exhibiting superior judgment and a balanced, realistic understanding of issues

The national salary range for this position is $270,000. to $290,000. USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on factors including experience, education, geographic location, internal equity, and market data. This position is also eligible for annual bonus, equity, benefits, and participation in the Company’s stock plan.