US Regulatory Affairs Director – Advertising & Promotion

Cytokinetics; San Francisco (CA); On-site; USD 225,000 - 263,000; Full time

Benefits offered by this job

Equity options

Health/dental/vision insurance

401k with employer match

Wellness stipend

Paid time off

Job summary

Cytokinetics is seeking a Director of Regulatory Affairs, Advertising and Promotion to lead strategic regulatory oversight for commercial, promotional, and medical communications in the US. You will ensure campaigns comply with FDA regulations and company policies while partnering with clinical, medical, and legal teams.

The role requires extensive experience in US advertising and promotion, with a proven track record of launches and strong ability to translate clinical data into compliant

Qualifications

• Expert knowledge of FDA regulations governing biologics and promotional compliance.
• Proficiency with electronic review systems, specifically Veeva Vault PromoMats.
• Ability to interpret complex clinical data into compliant marketing messages.
• Excellent written and verbal communication skills with executive-level stakeholders.
• Strong cross-functional collaboration skills to align marketing, medical, and legal stakeholders.

Responsibilities

• Lead regulatory review and approval of U.S. product promotional materials.
• Ensure product claims are supported by FDA-approved labeling and are scientifically substantiated.
• Serve as the regulatory advertising and promotion subject matter expert for the organization.
• Influence cross-functional decision making through strategic regulatory guidance.
• Mentor junior regulatory professionals and contribute to talent development initiatives.
• Lead continuous improvement efforts related to promotional review processes and governance.
• Represent regulatory on the MLR Committee, and provide strategic regulatory input during new concept reviews, and review and approve materials for regulatory compliance.
• Review non-promotional assets, including medical, corporate affairs, market access/payor communications, and patient advocacy materials.
• Develop and update Important Safety Information (ISI) and risk presentations for use in commercial assets for target audiences.

Skills

FDA regulations

Promo review

Strategic leadership

Cross-functional

Communication

Education

Bachelors degree

PharmD

PhD

JD

Tools

Veeva Vault PromoMats

Job description

Cytokinetics is seeking a Director of Regulatory Affairs, Advertising and Promotion to lead strategic regulatory oversight for commercial, promotional, and medical communications in the US. You will ensure campaigns comply with FDA regulations and company policies while partnering with clinical, medical, and legal teams.

The role requires extensive experience in US advertising and promotion, with a proven track record of launches and strong ability to translate clinical data into compliant