US Regulatory Affairs Director – Advertising & Promotion

Cytokinetics, Inc.; Radnor (Delaware County); Hybrid; USD 213,000 - 249,000; Full time

Benefits offered by this job

Equity in stock options and RSUs

Comprehensive health insurance

Dental insurance

Vision insurance

Life and disability insurance

401(k) with employer match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics, Inc. in Radnor, PA, is seeking a Director Regulatory Affairs, Advertising and Promotion to lead US promotional material reviews, ensure FDA labeling support, and shape regulatory strategy across marketing, medical, and legal teams.

This role requires at least 10 years in pharmaceutical/biotech regulatory affairs with 7 years in U.S. advertising and promotion, a strong track record of launches, and proficiency with PromoMats; hybrid work arrangement with competitive compensation and

Qualifications

• Bachelor’s degree required; PharmD/PhD/JD preferred.
• Minimum 10 years in pharmaceutical/biotech regulatory affairs.
• At least 7 years focused on U.S. advertising and promotion.
• Proven track record of successful launches for drug or biologic products.
• Direct history of managing OPDP interactions and submissions.

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 SME for the organization.
• Influence cross-functional decision making through strategic regulatory guidance.
• Mentor junior regulatory professionals and contribute to talent development.
• Lead continuous improvement efforts related to promotional review processes and governance.
• Represent regulatory on the MLR Committee and approval of materials for compliance.
• Review non-promotional assets such as medical, corporate affairs, market access/payor, and patient advocacy materials.
• Develop and update Important Safety Information (ISI) and risk presentations for commercial assets.
• Lead regulatory strategy for OPDP interactions and regulatory correspondence.
• Manage FDA Form 2253 submissions for applicable commercial assets.
• Lead voluntary advisory comment submissions for identified materials.
• Monitor OPDP trends and FDA guidance; communicate updates cross-functionally.
• Create or update SOPs to optimize workflows.
• Train U.S. marketing, sales, and medical affairs teams on regulatory compliance.

Skills

FDA regulations expertise

PromoMats (Veeva)

Regulatory strategy

Cross-functional collaboration

Executive communication

Education

Bachelor’s degree

PhD/MD/JD preferred

Tools

Veeva Vault PromoMats

Job description

Cytokinetics, Inc. in Radnor, PA, is seeking a Director Regulatory Affairs, Advertising and Promotion to lead US promotional material reviews, ensure FDA labeling support, and shape regulatory strategy across marketing, medical, and legal teams.

This role requires at least 10 years in pharmaceutical/biotech regulatory affairs with 7 years in U.S. advertising and promotion, a strong track record of launches, and proficiency with PromoMats; hybrid work arrangement with competitive compensation and