Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling; Fully Remote

• This is a critical role responsible for developing and executing regulatory strategy for product communications and core labeling.
• You will ensure commercial and non-promotional materials, as well as product labeling, comply with US FDA, EMA, and global regulations.

Key Responsibilities:

• Serve as regulatory lead for promotional and medical review committees, providing guidance on claims and fair balance.
• Direct development and maintenance of core, U.S., and patient labeling and lead health authority negotiations.
• Oversee vendors, budgets, and resources; travel approximately 20%.

Qualifications:

• 8+ years of biopharmaceutical regulatory experience, including at least 6 years in advertising and promotion.
• Expertise in FDA promotional regulations, labeling, MLR review, and OPDP interactions.
• Strong leadership, communication, and project management skills; experience with Veeva Promo Mats.
• The national salary range is $180,000 to $205,000 USD annually.
• This position is eligible for annual bonus, equity, benefits, and participation in the Company’s stock plan.

Kyverna Therapeutics is a biopharmaceutical company developing cell therapies for autoimmune diseases. It is a growth-stage biotech with a collaborative, solutions-oriented culture and a focus on regulatory excellence.