Director, US Regulatory Advertising & Promotion

Cytokinetics; South San Francisco (CA); Hybride; USD 225 000 - 263 000; Plein temps

Avantages offerts par ce poste

Health, dental, vision coverage

401k with employer match

Learning and wellness stipends

Paid time off

Résumé du poste

Cytokinetics, a specialty cardiovascular biopharmaceutical company, seeks a Director of Regulatory Affairs, Advertising and Promotion to lead US compliance for promotional and medical communications. You will partner with marketing, medical affairs, legal and clinical teams to ensure FDA-aligned messaging.

This role offers hybrid work in South San Francisco with a competitive base salary and equity, plus comprehensive benefits.

Qualifications

• Bachelor’s degree required; PharmD/PhD/JD preferred.
• 10+ years in pharmaceutical/biotech regulatory affairs.
• At least 7 years in US advertising and promotion.
• Proven launches for drug/biologic products.
• Direct history with OPDP submissions.
• Expert FDA regulation knowledge for biologics and promotional compliance.
• Proficiency with Veeva Vault PromoMats.
• Strong communication with executives.
• Cross-functional collaboration skills.

Responsabilités

• Lead US regulatory review and approval of promotional materials.
• Ensure claims align with FDA labeling and science.
• Serve as regulatory advertising and promotion SME.
• Mentor junior regulatory professionals.
• Lead improvements to review processes and governance.
• Represent regulatory on MLR Committee and advise on concept reviews.
• Review non-promotional assets for regulatory compliance.
• Develop and update Important Safety Information for assets.
• Lead OPDP interactions and regulatory correspondence.
• Manage FDA Form 2253 submissions for applicable assets.
• Lead voluntary advisory comment submissions.
• Train US marketing/sales/medical affairs on compliance.
• Create/update SOPs to optimize workflows.

Connaissances

FDA regulations

Veeva Vault PromoMats

Regulatory strategy

Cross-functional collaboration

Executive communication

Formation

Bachelor’s degree

PharmD / PhD / JD preferred

Outils

Veeva Vault PromoMats

Description du poste

Cytokinetics, a specialty cardiovascular biopharmaceutical company, seeks a Director of Regulatory Affairs, Advertising and Promotion to lead US compliance for promotional and medical communications. You will partner with marketing, medical affairs, legal and clinical teams to ensure FDA-aligned messaging.

This role offers hybrid work in South San Francisco with a competitive base salary and equity, plus comprehensive benefits.