Director, US Regulatory Affairs, Advertising & Promotion
Cytokinetics · Radnor, PA
RegulatoryFull-time$213k–$249kCompany career page
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Role summary
Cytokinetics seeks a Director of US Regulatory Affairs for Advertising and Promotion to lead strategic regulatory oversight of commercial communications and marketing materials. This role ensures FDA compliance across promotional campaigns, disease awareness initiatives, and corporate messaging while collaborating across clinical, medical, and legal functions.
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 compliance
- Proven track record of successful drug or biologic product launches
- Direct experience managing OPDP interactions and submissions
- Expert knowledge of FDA regulations for biologics and promotional compliance
- Proficiency with Veeva Vault PromoMats and electronic review systems
What you'll be doing
- Lead regulatory review and approval of US product promotional materials for FDA compliance
- Develop and maintain Important Safety Information and risk presentations for commercial assets
- Manage FDA Form 2253 submissions and voluntary advisory comment submissions
- Train marketing, sales, and medical affairs teams on regulatory compliance requirements
- Monitor OPDP enforcement trends and communicate updates to cross-functional stakeholders
Privacy & handoff
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