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Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling
Kyverna Therapeutics. Execute regulatory oversight for advertising, promotion, medical communications, and product labeling from pre-launch planning through lifecycle management .
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Annual bonus eligibility
- Equity
- Benefits
- Participation in the Company’s stock plan