Remote Assoc Director, Regulatory Advertising & Labeling

Kyverna Therapeutics; United States; Remote; USD 180,000 - 205,000; Full time

Benefits offered by this job

Annual bonus

Equity

Benefits

Stock plan

Job summary

Kyverna Therapeutics seeks an Associate Director, Advertising, Promotion and Labeling to lead regulatory oversight of promotional, medical, and labeling activities from pre-launch through lifecycle management. Remote work with West Coast hours is preferred.

The role requires expert interpretation of complex regulatory requirements and the ability to influence cross-functional teams to balance compliance with business goals. Reports to the SVP, Chief Regulatory Officer.

Qualifications

• Requires expert-level interpretation of regulatory requirements.
• Experience leading regulatory reviews for advertising and promotion.
• Proven ability to influence cross-functional teams to balance compliance and business goals.

Responsibilities

• Serve as regulatory lead for promotional and medical review committees.
• Provide strategic regulatory guidance on promotional materials and labeling across channels.
• Lead interactions with FDA OPDP and APLB including advisory comments and responses to enforcement letters.
• Collaborate on labeling negotiations with Health Authorities and global implementation.
• Develop and maintain core and local labeling and oversee cross-functional alignment.
• Establish and improve review processes, SOPs, and training; monitor regulatory guidance.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Regulatory judgment

Project management

Education

BS or MS in life sciences

MD/PhD/PharmD (preferred)

Tools

Veeva PromoMats

Job description

Kyverna Therapeutics seeks an Associate Director, Advertising, Promotion and Labeling to lead regulatory oversight of promotional, medical, and labeling activities from pre-launch through lifecycle management. Remote work with West Coast hours is preferred.

The role requires expert interpretation of complex regulatory requirements and the ability to influence cross-functional teams to balance compliance with business goals. Reports to the SVP, Chief Regulatory Officer.