Director, US Regulatory Affairs, Advertising & Promotion
Cytokinetics · South San Francisco, CA
RegulatoryFull-time$225k–$263kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Director-level regulatory affairs position overseeing FDA compliance for promotional materials, marketing campaigns, and medical communications at a cardiovascular biopharmaceutical company. Requires strategic leadership, cross-functional collaboration, and expertise in advertising and promotion regulations.
What they're looking for
- Bachelor's degree required; PharmD, PhD, or JD preferred
- Minimum 10 years pharmaceutical or biotechnology regulatory affairs experience
- At least 7 years focused on US advertising and promotion
- Proven track record launching drug or biologic products
- Direct experience managing OPDP interactions and submissions
- Expert knowledge of FDA regulations for biologics and promotional compliance
- Proficiency with Veeva Vault PromoMats electronic review systems
What you'll be doing
- Lead regulatory review and approval of US product promotional materials and ensure claims compliance
- Manage FDA submissions including Form 2253 and voluntary advisory comments
- Mentor junior regulatory professionals and drive continuous process improvement
- Train marketing, sales, and medical affairs teams on regulatory compliance requirements
- Monitor OPDP enforcement trends and communicate updates to cross-functional stakeholders
Privacy & handoff
This role links to Cytokinetics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.