Director, US Regulatory Advertising & Promotion

Cytokinetics; Philadelphia (Philadelphia County); Presencial; USD 213.000 - 249.000; Jornada completa

Descripción de la vacante

Cytokinetics is seeking a Director of Regulatory Affairs, Advertising and Promotion to lead regulatory strategy and oversight for US promotional materials. You will ensure FDA-compliant messaging and collaborate with marketing, medical, and legal to align strategy with compliance. The role includes mentoring staff and driving continuous improvement in review processes.

Requires extensive experience with OPDP, FDA interactions, and a track record of successful drug/biologic product launches.

Formación

• Bachelor's degree required; PharmD/PhD/JD preferred.
• Minimum 10 years in pharmaceutical/biotech regulatory affairs.
• 7+ years focused on US advertising and promotion.

Responsabilidades

• Lead regulatory review and approval of US product promotional materials.
• Ensure product claims are supported by FDA-approved labeling and are scientifically substantiated.
• Serve as regulatory advertising and promotion SME and mentor junior staff.

Conocimientos

Regulatory leadership

FDA regulations

US advertising and promotion

Cross-functional collaboration

Veeva Vault PromoMats

Educación

Bachelor's degree

PharmD/PhD/JD preferred

Herramientas

Veeva Vault PromoMats

Descripción del empleo

Cytokinetics is seeking a Director of Regulatory Affairs, Advertising and Promotion to lead regulatory strategy and oversight for US promotional materials. You will ensure FDA-compliant messaging and collaborate with marketing, medical, and legal to align strategy with compliance. The role includes mentoring staff and driving continuous improvement in review processes.

Requires extensive experience with OPDP, FDA interactions, and a track record of successful drug/biologic product launches.