Senior Director, Regulatory Affairs - Ad & Promotion (Remote)

Proclinical; United States; Remote; USD 180.000 - 220.000; Vollzeit

Zusammenfassung

Proclinical is seeking a Director, Regulatory Affairs, Advertising & Promotion for a dermatology-focused biotechnology company based in California. This remote-based role requires residency in the United States and leadership in promotional regulatory review.

The candidate will guide cross-functional teams, review materials for PRC, and stay current with FDA guidance and enforcement actions to ensure compliant communications across products and therapeutic areas.

Qualifikationen

• Bachelor’s degree in scientific discipline and 8-10 years of related experience.
• Strong understanding of regulatory requirements for promotion of prescription drugs.
• Experience reviewing promotional material for HCPs and patients.
• Knowledge of social media use in prescription drug communications.
• Experience using Veeva Vault for materials review.

Aufgaben

• Provide regulatory guidance and review for promotional, disease state, and non-promotional materials.
• Review materials in Veeva Vault and participate in PRC meetings.
• Evaluate perspectives from Commercial, Legal/Compliance, Medical and provide regulatory guidance across teams.
• Monitor enforcement actions and FDA guidance to inform internal policies and processes.
• Develop and implement regulatory ad promo strategies and manage complex negotiations with stakeholders.

Kenntnisse

Regulatory affairs

Promotional review

Cross-functional collaboration

FDA guidance interpretation

Social media pharma comms

Ausbildung

Bachelor's degree in life sciences

Tools

Veeva Vault

Jobbeschreibung

Proclinical is seeking a Director, Regulatory Affairs, Advertising & Promotion for a dermatology-focused biotechnology company based in California. This remote-based role requires residency in the United States and leadership in promotional regulatory review.

The candidate will guide cross-functional teams, review materials for PRC, and stay current with FDA guidance and enforcement actions to ensure compliant communications across products and therapeutic areas.